Third party manufacturing in pharma means a licensed, WHO-GMP certified company produces medicines for you, and you sell them under your own brand name. You skip building a plant, and the manufacturer handles production, testing and packaging. This is why third party pharma manufacturing is the most common way for new brands to enter the Indian market.

India has a large network of third party pharma manufacturers making tablets, capsules, injectables and syrups. Below you’ll find the top 10 third party manufacturing pharma companies in India, plus how to choose one, what it costs, and how long the first batch takes.

How to Select a Reliable Third Party Medicine Manufacturer in India?

A reliable third party medicine manufacturer in India can be identified by checking five key factors: valid WHO-GMP and DCGI approvals, in-house testing facilities, batch turnaround time, minimum order quantity flexibility, and packaging quality. Verifying these before signing a contract helps healthcare brands avoid compliance issues, production delays, and quality failures once manufacturing begins. Each factor is explained below to help you evaluate a manufacturing partner with confidence.

Verification of WHO-GMP Regulatory Approvals

It is always necessary to make sure that third party medicine manufacturing companies have valid WHO-GMP, ISO 9001:2015, and DCGI manufacturing approvals. Thus, certified units help to ensure compliance of your drug formulations with mandatory safety and efficacy standards.

Checking the In-House Testing Facilities

You need to pay attention to the presence of advanced testing facilities equipped with HPLC and stability chambers. Therefore, in-house quality controls help to confirm the purity and potency of the ingredients.

Evaluating Production Batch Turnaround Times

Reliable third party drugs manufacturers usually manage finished orders within 20 to 30 days. Hence, quick batch execution will prevent the problem of retail stock shortages.

Considering Minimum Order Quantity Options

Flexible options for Minimum Order Quantity beginning with 10 thousand tablets or 5 thousand liquid formulations are essential for preserving cash flow for pharmaceutical startups.

Choosing Packaging and Labeling Services

It is important to find manufacturers that offer such packaging options as leak-proof Alu-Alu, blister, and bottle packing lines. In addition, customized styling of labeling will help you to create strong brand differentiation and appeal among pharmacies.

List of Top 10 Best Third Party Medicine Manufacturers in India

Below is our curated top 10 pharmaceutical third party manufacturing companies in India list, chosen based on certifications, infrastructure and reliability.

Pushkar Pharma

Pushkar Pharma works with WHO-GMP-approved facilities that specialize in sterile injectables, ophthalmic solutions, and oral drops. The best third party medicine manufacturer in India produces more than 100 high-quality formulations, including antibiotics, analgesics and multivitamins. Having ISO certifications since 1993, the company offers customers the ability to produce formulations with customizable packaging and reliable 72-hour deliveries to domestic markets.

Theon Pharmaceuticals Ltd.

Theon Pharmaceuticals is one of the leading pharmaceutical manufacturing units based in Himachal Pradesh. The company manufactures different therapeutic ranges, including beta-lactam tablets, hard gelatin capsules and dry syrups. Holding WHO-GMP, ISO, and other accreditations, Theon offers high-output batches. Thus, healthcare brands rely on their fast deliveries, advanced analytical facilities and effective supply chains.

Akums Drugs & Pharmaceuticals Ltd.

Akums Drugs & Pharmaceuticals ranks among India’s largest third party medicine manufacturing companies and produces more than 12% of the formulations. The company has 15+ WHO-GMP-approved manufacturing facilities. Akums Drugs & Pharmaceuticals manufactures tablets, softgels, injectables and hormonal ranges. Moreover, continuous investments in R&D make it one of the preferred manufacturing partners for major pharma corporations.

Sun Pharmaceutical Industries Ltd.

Sun Pharma offers high-end contract manufacturing services in addition to the production of global branded products. Due to the modern facilities with global certifications, Sun Pharma manufactures complex formulations, specialty drugs, neuropsychiatry ranges and chronic care tablets. Technical skills help to ensure chemical batch consistency. Consequently, brand companies use the technical scale of Sun Pharma to ensure international compliance and quality controls.

Cipla Ltd.

Cipla provides state-of-the-art third-party manufacturing services and specializes in respiratory formulations, inhalers and oral solid doses. Having a long history of successful formulation, WHO-GMP facilities of Cipla comply with global safety guidelines. Hence, brands have access to advanced manufacturing technologies, stable aerosol drug delivery systems and quality assurance protocols in complex therapeutic segments.

Lupin Ltd.

Lupin is a global pharmaceutical leader that offers specialized contract production in anti-tuberculosis, cardiovascular and diabetes formulations. Having WHO-GMP and US-FDA approval for manufacturing sites, Lupin helps partner companies to receive high-quality formulations with stable data and sophisticated packaging configurations that ensure long-term drug potency.

Dr. Reddy’s Laboratories Ltd.

Dr. Reddy’s Laboratories works with modern contract manufacturing units that focus on active ingredients, biosimilars and oral solids. The best company for third party medicine manufacturing in India provides full support from formulation development to final commercial packaging. Hence, advanced analytical laboratories and quality control processes ensure that every batch complies with international pharmacopoeia standards.

Zydus Lifesciences Ltd.

Zydus Lifesciences works with modern facilities that manufacture biologicals, vaccines, tablets and topical ointments. Maintaining ISO and WHO-GMP compliance, Zydus Lifesciences offers partners the opportunity to work with high-speed automated packaging facilities and a robust QA team. Hence, companies get the opportunity to scale production quickly without facing bottlenecks in capacity.

Alkem Laboratories Ltd.

Alkem Laboratories operates with an extensive production network of top-tier anti-infective, gastrointestinal and pain management medicines. WHO-GMP-compliant units of this best company for third party medicine manufacturing in India help to benefit from cost-effective batch production rates, extensive formulation capabilities and quick product deliveries.

Mankind Pharma Ltd.

Mankind Pharma operates with scalable third party manufacturing for fast-moving consumer healthcare products, OTC drugs and prescription formulations. Having high-capacity manufacturing facilities equipped with granulating and tableting machines, Mankind Pharma helps to receive highly competitive net pricing for batch sizes, full packaging customization and nationwide distribution.

What Services Do Top Third Party Medicine Manufacturers Provide?

Top third party medicine manufacturers provide four main services: formulation development, regulatory and licensing support, custom packaging, and commercial batch production. Regulatory support takes 5–7 days, formulation development takes 10–15 days, packaging takes 7–10 days, and full batch production takes 15–20 days. See the table below for full details on each service.

The Bottom Line

Outsourcing production to certified third party medicine manufacturing companies is the fastest and most cost-effective solution to expand your pharmaceutical brand without heavy infrastructure investments. Partnering with the right third party manufacturing pharma companies also gives you access to advanced R&D and testing without the overhead. Moreover, WHO-GMP factories will ensure safety as well as total compliance with the regulations.

Thus, using the services of such third party medicine manufacturing firms as Pushkar Pharma, you will get sterile injectable medicines, special drops, unique packaging & fast delivery all over the country. Work with top-quality third party drugs manufacturers like Pushkar Pharma today in order to optimize your supply chain and increase profits.

Frequently Asked Questions

How much money is required as a minimum for third party medicine manufacturing?

The minimum budget for third party medicine manufacturing companies ranges from 50 thousand to 5 lakhs. The budget includes small batch manufacturing, packaging design & licensing. 

Is a Wholesale Drug License necessary for third party manufacturing? 

Yes, it allows your company to market, store, and distribute pharmaceutical products legally across India.

What certifications should I check in a contract manufacturing unit?

It is always necessary to check WHO-GMP, ISO 9001:2015, and DCGI manufacturing approvals. These certifications ensure compliance with safety, hygiene, and quality standards.

How many days will the first product batch be delivered within?

It would take 30 days to deliver the first product batch because of artwork and label approvals. However, repeat batches will be delivered within 15 to 20 business days.

What is the difference between third party and PCD pharma manufacturing?

Third party manufacturing involves large custom batch production under your own brand name. On the contrary, the PCD model implies regional distribution rights for pre-existing parent company brands.

Which packaging styles offer the best protection against humidity?

Alu-Alu blister packaging provides maximum protection against ambient humidity, light and heat. Hence, it increases the shelf stability of sensitive formulations like antibiotics and multivitamins.

Can I order small batch sizes as a startup pharma brand?

Yes, many best third party medicine manufacturer in india choices accept low initial Minimum Order Quantity beginning with 10 thousand tablets or 5 thousand bottles. 

How are net production rates calculated by contract manufacturers?

Prices are calculated according to the cost of raw materials, packaging types, batch size and testing charges. Larger batch volumes greatly decrease unit prices for brand owners.

What happens if a manufactured batch fails quality control tests?

If a batch fails quality control tests, then the lot will be rejected. Good third party medicine manufacturing companies reformulate and remanufacture the batch at their own expense in order to protect patient safety.

Why do major pharma brands choose contract manufacturing over owned plants?

Contract manufacturing eliminates huge capital expenditures for land, heavy machinery and maintenance. Hence, brands allocate their capital for marketing, doctor detailing and sales.

Every year, healthcare systems across Africa, Central Asia, and Eastern Europe depend on pharma exporters who can guarantee two things: consistent medicine quality and delivery they can plan around. Pushkar Pharma, based in India, has built its reputation on exactly that — WHO-GMP certified manufacturing, full-batch quality testing, and export documentation built for international regulatory authorities across Africa, Central Asia, and Eastern Europe.

As one of India’s established medicine exporters, we manufacture and supply injectables, ophthalmic formulations, nasal and ear drops, and external preparations to distributors, healthcare buyers, and government tenders worldwide. From formulation and manufacturing to regulatory dossiers, private labeling, and export logistics — international buyers work with a single accountable partner instead of coordinating five different vendors.

What Makes a Reliable Pharma Exporter and Manufacturer in India?

A reliable pharma exporter is built on five fundamentals:

• WHO-GMP certified manufacturing
• Manufacturing capacity that scales with order volume
• Independent, multi-stage quality control
• Country-specific regulatory dossier preparation
• Transparent, itemized export pricing

Buyers evaluating pharma exporters and medicine exporters from India check all five before placing a first purchase order — a gap in any one of them creates delays once real shipments start moving.

WHO-GMP Certified Manufacturing

As a WHO-GMP certified pharmaceutical manufacturer, every production line at Pushkar Pharma runs under strict GMP protocols, so each batch is consistent, safe, and compliant with international drug manufacturing standards before it ever reaches export documentation. This certification is typically the first checkpoint overseas regulatory bodies — including national medicines authorities across Africa, Central Asia, and Eastern Europe — verify before approving a new pharma manufacturer.

Manufacturing Capacity That Scales With Demand

Industrial-scale bulk pharmaceutical manufacturing facilities let Pushkar Pharma handle large-volume export orders without production delays or quality drop-off. Buyers placing a pilot order with a bulk order pharma manufacturer can scale up as demand grows in their market, without needing to re-qualify a new supplier or restart the registration process.

Independent, Multi-Stage Quality Control

A dedicated quality assurance team runs batch testing for chemical composition, stability, and purity at every production stage — not only at final release. This kind of ongoing pharmaceutical quality control catches deviations mid-process, rather than after a batch is complete, protecting product safety and keeping shipment timelines on track.

Country-Specific Regulatory Dossier Preparation

Our regulatory affairs specialists prepare complete CTD and eCTD dossiers — the core drug registration documentation — tailored to each destination country’s requirements. This is critical for customs clearance and product registration with the relevant national drug authority, whether that’s a tender board in East Africa or a ministry of health in Central Asia.

Transparent, Itemized Export Pricing

Clear, batch-level cost breakdowns give international buyers competitive pharma export pricing they can plan procurement budgets around, with no additional costs surfacing after the purchase order is placed.

How Do Global Medicine Suppliers Ensure Quality and Regulatory Compliance?

Global medicine suppliers ensure quality and regulatory compliance through four checks applied to every batch before shipment: raw material inspection, automated production, finished-product stability testing, and destination-specific regulatory documentation. Together, these checks confirm a batch is both chemically sound and legally cleared for import before it ever leaves the facility.

Strict Raw Material Inspection

Active pharmaceutical ingredients (APIs) and excipients are tested against pharmacopeial standards before production begins. Systematic supplier audits and incoming raw-material verification prevent substandard inputs from entering the active manufacturing line — the most common root cause of batch rejection industry-wide.

Standardized, Automated Production

Automated manufacturing lines minimize human contact and contamination risk during pharmaceutical production. This keeps dosing accuracy, uniform bioavailability, and physical stability consistent across every batch, whether the order is a pilot shipment or a large-volume export run.

Finished-Product Stability Testing

Quality assurance teams test completed products under accelerated stability conditions — including elevated humidity and temperature — to confirm each formulation holds its active properties for its full declared shelf life, a requirement most destination regulators check directly against submitted stability data.

Export Regulatory Documentation

Our regulatory affairs team compiles CTD-format dossiers and stability reports matched to each destination country’s import requirements, so customs clearance and product registration move through the relevant national drug authority without avoidable delays.

What Should Businesses Consider When Choosing a Global Medicine Supplier?

When choosing a global medicine supplier, look at five things: certifications, order flexibility, clear pricing, reliable delivery, and packaging support. If any one of these is weak, it usually shows up later — as a delayed shipment, a customs problem, or a surprise cost — not on day one.

These five checks are what separate a supplier you can count on from one that looks good in a first email but causes problems once you actually place an order.

Why Choose Pushkar Pharma as Your Pharma Exporter and Manufacturer?

Pushkar Pharma stands out on five things: production scale, pricing, bulk export experience, regulatory support, and international reach.

High-Capacity Manufacturing

Our manufacturing units are built to produce large volumes of certified medicines without slowing down. High-speed, automated machinery makes tablets, capsules, liquids, and ointments to a consistent standard, whether you’re ordering a first batch or a full production run.

Competitive Export Pricing

We offer clear, competitive pricing for export orders — reach out for a batch-specific quote. International partners get premium-grade medicines from a bulk pharma exporter in India without paying a premium for the relationship.

Real Experience With Large Export Orders

Handling a large international shipment is different from handling a local one — customs paperwork, cold-chain logistics, and multi-country compliance all add complexity. Pushkar Pharma manages this end-to-end, so your inventory arrives complete, correctly documented, and on schedule.

Fast, Reliable Regulatory Support

Our regulatory team prepares the technical documents and stability data your local health authority needs to approve a new product. That means less waiting and fewer surprises when you’re trying to launch a new product line.

Which Countries Does Pushkar Pharma Export Injectables To?

Pushkar Pharma is a WHO-GMP certified pharma manufacturer and exporter supplying injectables, ophthalmic formulations, and general pharmaceuticals to distributors and government tenders across Africa, Central Asia, and Eastern Europe.

*Actively expanding registration into these markets.

Every destination gets local product registration support, batch-level quality testing, and packaging adapted to regional language and regulatory requirements.

The Bottom Line

Choosing the right pharma exporters and medicine exporters comes down to three things: certified manufacturing you can verify, pricing you can plan around, and a regulatory team that gets your product cleared without delays. Pushkar Pharma delivers all three — WHO-GMP certified production, transparent batch pricing, and dossiers built for 17 countries across Africa, Central Asia, and Eastern Europe.

Whether you’re placing a first pilot order or scaling an existing supply relationship, working with an established pharma manufacturer means fewer surprises at every stage — from formulation to customs clearance.

Ready to move forward?

Request a quote or download our product catalogue to see full specifications and pricing for your target market.

Frequently Asked Questions

Why should you choose a bulk pharma exporter in India?

India can offer cost-effective manufacturing, WHO-GMP certified facilities, & large chemical synthesis capabilities. Thus, international buyers can reduce their operational expenses significantly.

How do the exporters manage temperature-sensitive medicines?

The exporters use the validated cold-chain containers with real-time temperature loggers. As a consequence, the heat-sensitive formulations stay completely potent during the international shipment.

What is the initial order value for export batches?

The commercial export batches usually start around ₹1.5 lakh based on product type. Moreover, the flexible conditions permit the importers to increase their inventories gradually.

Does Pushkar Pharma provide private label contract manufacturing?

Yes, Pushkar Pharma can design the custom packaging and handle the specialized brand labeling. Thus, the clients establish branded product presence in target markets effortlessly.

What quality control measures apply to exported raw materials?

The raw materials undergo HPLC testing, microbial limit tests, and assay checks. Thus, only the verified active ingredients enter the final formulation stage.

How long does custom formulation manufacturing take?

The standard production cycle takes about 30-45 days after the design approval. Thus, the batch planning stays predictable for the international sales team.

What payment terms apply to large export orders?

The exporters offer advance telegraphic transfers or irrevocable Letters of Credit. Thus, the financial transaction stays safe and transparent for both trading parties.

Why is WHO-GMP certification important for global trade?

The WHO-GMP certification ensures that the products comply with international safety and hygiene standards. Consequently, the regulatory authorities authorize market entry much faster.

India’s pharmaceutical sector has become one of the fastest-growing manufacturing hubs in the world, with the domestic market valued at around Rs. 5,20,000 crore (US$ 60.32 billion) in 2026, projected to grow to Rs. 6,89,000 crore (US$ 79.74 billion) by 2031. A major driver behind this growth is outsourced production: the contract manufacturing segment held a 53.2% share of the market in 2023 and continues to grow as more companies shift toward external manufacturing partners, rather than building their own plants. Grand View Research. (Source – Big Adda)

This shift has made third-party manufacturing one of the most accessible ways to enter the pharma business in 2026 — whether you’re a startup, a PCD franchise business, or an established brand looking to expand your product range without capital-heavy infrastructure. This guide breaks down exactly how third-party manufacturing works in India: the process, the top WHO-GMP certified companies, the PCD franchise model, and what to evaluate before choosing a manufacturing partner.

What is Third-Party Manufacturing in Pharma?

Third-party manufacturing in pharma is when a brand owner outsources drug production to a licensed, WHO-GMP certified manufacturer, then sells the finished medicines under its own brand name. The manufacturer owns the factory, raw materials, production process, and quality testing; the brand owner handles branding, marketing, and distribution. For example, a company selling “ABC Pharma” tablets doesn’t operate a plant — a certified third-party manufacturer produces, tests, and packs the tablets under the ABC Pharma label instead of its own. This model is widely used in India’s pharmaceutical sector as of 2026 to launch new brands without factory investment.

List of Top 10 Pharmaceutical Third Party Manufacturing Companies in India

Pushkar Pharma

Pushkar Pharma produces premium-grade pharmaceutical products across various dosage forms. Their product list consists of anti-infective tablets, pediatric suspensions, and GI disorders capsules. What is also important – Pushkar Pharma facilities are ISO and WHO-GMP certified. Their key advantages are cost-effective net rates, fast batch delivery in 48 hours, accuracy of formula production and flexibility in setting minimum quantities.

Akums Drugs & Pharmaceuticals Ltd.

Akums Drugs & Pharmaceuticals represent one of the largest third party manufacturing pharma companies in India. Akums produce vast ranges of formulations including softgel capsules, oral liquids, tablets, and dry powder injections. Akums run several WHO-GMP and USFDA compliant facilities. The strengths of the company involve rapid manufacture on a mass scale, sophisticated research abilities, regulatory document support, and constant quality of batch productions.

Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries represents the best option among top 10 pharmaceutical third party manufacturing companies in India that has wide manufacturing capacities across various fields of treatment. Their formula list includes chronic cardiology formulas, neurology tablets, oncology injectables, and respiratory products. The company’s production plants possess WHO-GMP and USFDA certifications. Their main strengths include world class formula production, testing process, constant stock supply, and international regulatory compliance.

Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories manufactures unique pharmaceutical manufacturing for complex generics and active ingredients. They have a great formula list that includes cardiovascular capsules, gastro-intestinal disorders suspensions, antidiabetic treatments and biological formulas. Dr. Reddy’s Laboratories operate facilities with WHO-GMP certificates. Their key strengths include high-quality analytical testing laboratories, formula purity, sustainable production techniques, and global distribution channels.

Cipla Ltd.

Cipla stands for production of latest generation respiratory, anti-asthmatic and critical care pharmaceutical products. Plus, Cipla manufacture metered dose inhalers, respules, antiretroviral tablets, and topical ointments. Cipla’s manufacturing facilities run strictly under the regulations of WHO-GMP and international regulatory bodies. Cipla’s key strengths involve innovative inhalation technology development, quality assurance measures, large batch production, and high level of clinical trust in domestic market.

Lupin Ltd.

Lupin specializes in anti-tuberculosis medicines, cardiovascular tablets & cephalosporin products. Their manufacturing range comprises oral solids, liquid suspensions, and sterile injectables. Lupin’s manufacturing units comply with international and WHO-GMP certificates. Lupin’s main strengths are involved in advanced research facilities for formulas, large production efficiency, strict raw materials procurement, and regulatory compliance expertise for global markets.

Aurobindo Pharma

Aurobindo Pharma specializes in high-volume production of API and formulated dosages. The range includes beta-lactam antibiotics, dietary supplements, and CNS treatments. Aurobindo’s production plants hold WHO-GMP certificates. Key strengths of the company include integrated manufacturing ecosystem, cost leadership, rapid product development, and large warehousing capacity.

Zydus Lifesciences

Zydus Lifesciences manufacture vaccines, biosimilars, gastrointestinal liquid preparations, and pain management tablets. Their production plants hold WHO-GMP and ISO certificates. The strengths of Zydus Lifesciences involve biotechnology research, strong quality management systems, broad range of therapeutics, and reliable contractual delivery times for business partners.

Torrent Pharmaceuticals

Torrent Pharmaceuticals focuses primarily on niche therapeutic segments including cardiovascular, CNS and Gastro-metabolic formulas. They manufacture sustained-release tablets and pediatric syrups. They have WHO-GMP accredited manufacturing facilities. Their strengths are involved in precise dose manufacturing, rigidity of laboratory safety checks, customer support and consistent packaging.

Alkem Laboratories

Alkem Laboratories produce a wide range of anti-infectives, nutraceuticals, analgesics, and dermatological formulations. Alkem’s production facilities hold WHO-GMP, ISO and international quality certificates. Main operational strengths of the company include massive annual production capacity, nationwide logistics network, competitive trade pricing, and high brand recognition among business partners.

How Does Third-Party Pharmaceutical Manufacturing Function in India?

To clearly graspthird party manufacturing in pharma, it will be useful to find out how outsourcers fulfill orders from beginning till completion of the project. This is done through reliable third party manufacturing pharma companies:

What Are the Advantages and Factors to Consider in Pharmaceutical Third Party Manufacturing?

Cost-Effective Production Model

By understanding what is third party manufacturing in pharma, entrepreneurs understand that this production method excludes any capital expenditures on construction of land, machines & salaries for workers. In that way, business entities manage to save millions of dollars while obtaining high-grade formulations at competitive trade prices.

Access to Certified Manufacturing Facilities

Another advantage of working with pharmaceutical third party manufacturing partners is that they ensure the production in WHO-GMP and ISO certified facilities. As a result, entrepreneurs get products with high dosage accuracy, pure formulation and freedom from any contamination during the manufacturing process.

Focus on Expansion of Marketing Activities

Furthermore, by choosing reliable third party manufacturing companies of India you will manage to free the whole management team from unnecessary responsibilities. This will allow you to allocate all your funds for promotion and distribution activities.

Broader Portfolio of Formulations Available

When choosing third party manufacturing companies for pharmaceutical formulas you immediately obtain access to broad portfolios including many dosage forms: tablets, capsules, injections, suspensions, and so forth. This will help to diversify your product range rapidly and efficiently.

Flexible Batch Orders Quantities

As part of evaluating what is third party manufacturing in pharma, one may notice that contract partners provide the opportunity of placing relatively small orders of batch orders. Thus, startup businesses will be able to launch products without any risk and scale production later on increasing demand.

Conclusion

Outsourcing of the manufacturing is the most effective and efficient way of doing business for all modern healthcare companies in India. By understanding what is third party manufacturing in pharma entrepreneurs have an opportunity to launch high-quality products without heavy investments in factories. The choice of reliable partner will include the analysis of WHO-GMP certificates, open pricing and fast stock delivery.

Frequently Asked Questions

What is the distinction between third-party manufacturing & contract manufacturing?

The former involves smaller batch sizes and formulations already in place, whereas the latter often includes custom manufacturing over bigger scales for a long time.

What documents are needed to start third-party manufacturing in India?

These include drug license (DL) number, GST number, non-resemble certificate, and approved brand names.

Why should small pharmaceutical startups use outsourced production?

This significantly reduces initial entry barriers by getting rid of the cost of setting up the factory itself; thus, all efforts can be devoted to marketing and distribution of products.

What is the lead time for the very first batch order?

The first batch usually takes 30 to 45 days because of packaging design approvals, while other orders can be delivered within 20-30 days.

Does third-party manufacturing imply independent laboratory testing?

Yes, the manufacturers make very detailed raw materials testing and issue a Certificate of Analysis for each finished batch.

Is there an option of customizing the formulation ingredients for third-party manufacturing?

Yes, usually, the vast majority of certified manufacturers provides such service as long as the combination of ingredients is DCGI-approved.

In India, manufacturing medicine without a valid license is a serious crime. A license means that your manufacturing plant complies with Good Manufacturing Practices (GMP), uses quality raw materials and adheres to stringent hygiene standards.

It also allows you to market, export and sell pharmaceutical formulations legally across state and international borders. Applying for a license can feel tricky at first. Thanks to a large number of forms to fill and papers to gather. However, things can get easier if you know the steps to meet drug manufacturing license eligibility. This is what we did in this very guide.

If you don’t go through the hassles of licensing, you can hire a contract manufacturer like Pushkar Pharma. Let’s get started.

2026 Drug Manufacturing License Eligibility Requirements

To get a drug manufacturing license in India in 2026, you need a GMP-compliant facility, qualified technical staff (B.Pharm with 18+ months experience), and a quality control expert on-site. Apply via Form 24 through the Sugam portal or your state FDA portal, submit required documents, pass document review and site inspection, then receive Form 25 (or Form 28 for Schedule C/C1 drugs). The process takes 60-90 days.

There are some criteria that applicants must meet before applying, such as space, technical expertise, and equipment.

Some of the key Considerations for drug manufacturing license eligibility

1. Qualified Technical Staff:

Your unit should have qualified staff on a full-time basis to qualify for a drug manufacturing license. You will need a graduate in pharmacy (B.Pharm) with a minimum of 18 months of practical experience in drug manufacturing. It is a basic yet important step to get your medicine manufacturing license.

2. Quality Control Expert:

One of the major requirements for drug manufacturing license eligibility is to involve a qualified testing analyst who has a degree in Pharmacy, Chemistry or Microbiology and relevant laboratory testing experience.

3. Space and layout:

Ensure you have enough space for your drugs. But keep in mind that the space should be created according to the type of drugs.

4. Compliance with GMP (Revised Schedule M):

Your facility layout, ventilation and sanitation systems should be compliant with revised GMP standards.

All the drug manufacturing licenses meet the eligibility criteria, so there is no problem in getting approval during the official site inspection.

Types of Drug Manufacturing Licenses in India

As per your business model, there are various types of licenses you can apply for:

• Formulation Manufacturing License:

This is needed for manufacturing finished goods such as tablets, syrups or ointments.

• Bulk Drug (API) License:

This is needed to manufacture Active Pharmaceutical Ingredients that are used as the base materials in medicines.

• Loan License:

If you want to manufacture medicines using the equipment and premises of another licensed manufacturer, then this license is issued.

• Repackaging License:

It is required to repackage drugs from bulk containers into retail packs. It is a key important drug manufacturing license eligibility.

CDSCO vs. State FDA approval: What’s the Difference?

Knowing the difference helps you file your application with the right regulatory authority.

State Licensing Authority (State FDA/SLA):

State-level manufacturing licenses for standard formulations, bulk drugs and routine site inspections.

CDSCO (Central Drugs Standard Control Organisation):

CDSCO gives approvals for new drugs, clinical trials, imported drugs and large-scale manufacturing facilities.

For most routine pharmaceuticals, your main interface would be with the State FDA. But for new molecules or new formulations, you need clearance from the central CDSCO.

Documents Required for a Drug Manufacturing License

Here is the list of important documents for drug manufacturing license application in 2026:

• Form 24 (Application for licence grant/renewal)
• Proof of constitution of the firm (Partnership deed, MOA/AOA or Registration certificate)
• Site plan and detailed layout of the manufacturing premises
• Ownership documents or lease agreement for the property
• Qualification and experience certificates of technical manufacturing and testing personnel
• Plant machinery, equipment and laboratory testing tools list.
• No Objection Certificate (NOC) from local municipal authorities and Pollution Control Board
• Safety certificates (Fire NOC, etc)

To avoid administrative delays, check every item on this list of documents required for drug manufacturing license applications.

How to Apply for a Drug Manufacturing License: Step-by-Step

The process of getting a pharma manufacturing license in India is an important part of being compliant from start to end.

Step 1: Design a Facility in Compliance

Construct your plant in compliance with Revised Schedule M. Incorporate suitable cleanroom zoning, HVAC air filtration and dedicated storage for both raw materials and finished goods.

Step 2: Apply Online

Submit your application either on the Sugam portal or the online FDA portal of your state. Submit the required papers with the prescribed government fee.

Step 3: Document check

Drug inspectors check your application file. If something is needed, reply fast.

Step 4: Site Inspection

A team of Drug Inspectors (State FDA and CDSCO, as applicable) will visit your premises to test machinery, inspect sanitation and verify technical staff credentials to confirm your eligibility for a drug manufacturing license.

Step 5: License Granted

Once your plant passes, you get Form 25. Some Schedule C and C1 drugs need Form 28 instead.

Don’t Want to Go Through the License Hassle? Pushkar Pharma Can Help

Obtaining a pharmaceutical manufacturing license in India is difficult, time-consuming, costly, and requires regulatory know-how. It is easy to see why many pharmaceutical companies, distributors and entrepreneurs choose a third-party manufacturer. A third-party pharma manufacturer produces and labels medicines on behalf of their client. This way, it saves them costs and hassles associated with a drug manufacturing license.

If you are looking for such a manufacturer, Pushkar Pharma has got you covered. Pushkar Pharma is an Indian pharmaceutical company that specialises in the manufacturing of quality drugs, PCD pharma franchising, and third-party contract manufacturing services.

• They have world-class production units with strict WHO-GMP standards.
• It takes care of the entire end-to-end production cycle right from formulating and sourcing raw materials to regulatory compliance and packaging. I
• If you want to start your own product line under a loan license or want to expand your production, Pushkar Pharma is the right partner for you.

To know more, please contact us at  +91-9355622444 and  +91 94661 82151.

Frequently Asked Questions

1. How long does it take to get a drug manufacturing license in India?

It can take 60 to 90 days from the date of submission.

2. What is the minimum qualification required to get a drug manufacturing license?

The manufacturing supervisor should be a B.Pharm graduate with a minimum of 18 months of experience in drug manufacturing.

3. Can I manufacture medicines with a third-party company?

Yes, you can. All you need to secure a Loan License to manufacture medicines at any existing WHO-GMP certified unit like Pushkar Pharma.

4. How long is the drug manufacturing license valid in India?

Under current rules, once you get a manufacturing license, it is yours forever as long as you pay the retention fee every 5 years.