6 Easy Steps for Third Party Manufacturing in Pharma

The pharmaceutical industry in India is experiencing rapid growth, with an increasing number of entrepreneurs and businesses entering the market. One of the most efficient and cost-effective methods to launch or expand a pharma business is through third party manufacturing, also known as contract manufacturing. This model allows companies to outsource the production of their products to an established manufacturer without having to set up their own manufacturing unit.

Whether you're a startup, a marketing company, or an established pharma business looking to diversify your product range, understanding the step-by-step process of third party manufacturing is essential for smooth operations and regulatory compliance.

In this article, we present 6 easy steps for third party manufacturing in pharma, guiding you through the essential processes involved in bringing your products to market successfully.

Step 1: Finalize Your Product List and Composition

The first and most crucial step is deciding on the products you want to manufacture. This includes:

• Therapeutic segments (e.g., antibiotics, dermatology, cardiac-diabetic, nutraceuticals)

• Dosage forms (tablets, capsules, syrups, injections, etc.)

• Composition and strength of each product

Take the time to perform market research, competitor analysis, and understand the demands of doctors and chemists in your target area. Consulting a medical practitioner or expert in pharma marketing can also help validate your product selection.

Pro Tip: Go for DCGI-approved compositions to ensure credibility and safety.

Step 2: Choose a Reputable Third Party Manufacturer

Once your product list is ready, the next step is selecting a WHO-GMP certified third party manufacturer. Key factors to consider when choosing a manufacturer include:

• Certifications: WHO-GMP, ISO, FSSAI (for nutraceuticals)

• Production capacity

• Product range

• Reputation and client feedback

• Timely delivery and consistency in quality

Request a product catalogue and price quotation from multiple manufacturers to compare offerings. Visiting the manufacturing facility (if possible) gives you an added assurance about hygiene, production standards, and infrastructure.

Useful Tip: Many top third party manufacturers in India also offer branding, packaging, and promotional support.

Step 3: Legal Documentation and Company Profile Submission

Before production can begin, you must provide several documents and basic company details to the manufacturer:

Required Documents:

1. Company Profile: Brief about your firm with address and contact details.

2. Drug License: Issued by the Drug Controller and Licensing Authority in your state.

3. GST Registration Certificate.

4. PAN Card of the proprietor or company.

5. Adhaar Card and Photograph of the authorized signatory.

6. Signed Agreement or Purchase Order (as per manufacturer’s format).

If you're a marketing company, ensure you have a valid marketing license. This step is essential for legal compliance and order processing.

Step 4: Design and Finalize Product Packaging

Pharma is not just about quality products—it’s also about professional and appealing packaging. After documentation, collaborate with the manufacturer or a graphic designer to finalize:

• Brand Name and Logo

• Product Packaging Design (blister packs, bottles, boxes, labels)

• MRP, Batch No., Expiry Date, etc.

• Language preferences (e.g., English, Hindi, regional languages)

• Regulatory info (schedule drugs, storage instructions)

Make sure your packaging complies with D&C Act, 1940 and Rules, 1945, especially if you’re marketing Schedule H or Schedule X drugs.

Note: Once approved, packaging materials like cartons and foils are printed, so double-check all details to avoid costly reprints.

Step 5: Product Manufacturing and Quality Assurance

Once designs and raw materials are approved, the actual manufacturing process begins. This typically involves:

• Procurement of raw materials and active ingredients (APIs)

• In-house testing of raw materials to meet quality standards

• Batch-wise production, as per GMP protocols

• In-process quality checks and standard operating procedures (SOPs)

After manufacturing, finished goods are subjected to final testing in QC labs. Certificates of Analysis (CoA) are provided for each batch to ensure efficacy, safety, and compliance.

Average Timeframe:

• First batch: 30–45 days (due to material procurement & design finalization)

• Subsequent batches: 15–20 days

Step 6: Delivery and Marketing of Products

Once the products clear quality checks and regulatory documentation, they are packed and dispatched to your location via logistics partners. Before dispatch, manufacturers often provide:

• Batch Manufacturing Record (BMR)

• Analysis Report / CoA

• Invoice and Billing Documents

• Packing List

Make sure you receive all supporting paperwork along with the goods. These documents are crucial for marketing, distribution, and record-keeping.

With products in hand, your role shifts to marketing and sales. This may include appointing medical representatives (MRs), promoting products to doctors, retailers, and pharmacies, and using digital marketing strategies for brand awareness.

Bonus Tips for Successful Third Party Manufacturing:

1. Start with a few high-demand SKUs to minimize initial risk.

2. Build a strong relationship with your manufacturer for better support.

3. Regular follow-ups ensure timely production and updates.

4. Always check for regulatory updates to maintain compliance.

5. Invest in your brand presence through quality promotional tools (visual aids, brochures, samples).

Advantages of Third Party Pharma Manufacturing

• Cost-Effective: Saves the cost of plant setup, equipment, and manpower.

• Scalability: You can increase your product line without increasing infrastructure.

• Focus on Marketing: With manufacturing off your plate, you can invest time in brand building and customer relationships.

• Assured Quality: WHO-GMP certified manufacturers maintain strict quality protocols.

• Quick Market Entry: Ideal for new entrepreneurs with limited capital.

Bottom Line

Starting a pharma business through third party manufacturing is a smart move for aspiring entrepreneurs and businesses looking to expand their reach. By following these 6 easy steps, you can streamline the process—from selecting products to getting them delivered with the right compliance and quality.

Third party manufacturing not only allows for flexibility and cost-saving but also offers scalability in today’s competitive pharmaceutical landscape. With the right partner, proper documentation, and clear planning, you can create a successful and profitable pharma brand without owning a manufacturing plant.

At EthixElite Lifesciences Private Limited, we assist businesses at every step of their third party manufacturing journey—from product selection and formulation to packaging and compliance. With our network of WHO-GMP certified manufacturers, transparent processes, and client-first approach, we ensure that your pharma venture gets the right start and sustained growth.

For inquiries and partnerships, connect with EthixElite Lifesciences Private Limited today and take your pharma business to the next level.