The significance of third party pharma manufacturing process cannot be overstated. It provides companies with the opportunity to obtain production of top-tier quality medicines without the need to establish manufacturing facilities. Contract manufacturing is a strategy used by a number of well-established pharmacy businesses where the manufacturing is done in expert plants certified by the WHO and Good Manufacturing Practices (GMP), and they can focus on marketing, branding, and distribution to the clients.

This blog aims to define the process of third party pharma manufacturing, detail the various steps it entails, and consider the benefits of such a strategy to pharma companies on the Indian subcontinent.

What is Third Party Pharma Manufacturing?

Also described as contract manufacturing, third party pharmacy manufacturing is a business model where production of pharmaceutical products is contracted to be completed by a different manufacturing unit. The contracted party is responsible for every aspect of production, from the procurement of raw materials to finished packaging and provides the service branding for the ordering company. This model enables pharmacy businesses to lower their operational costs.

Example:

If a company like Impelled Remedies needs to produce a batch of tablets or syrups, it can collaborate with a Third Party Manufacturing Company that has the required machinery, licenses, and manpower to handle production efficiently.

Step-by-Step Process of Third Party Pharma Manufacturing

Here’s a detailed 6-step process of how third party pharma manufacturing works:

Step 1: Selection of Products and Manufacturer

The first step is to finalise the product list and choose a reliable third party manufacturer. tablets, capsules, syrups, ointments, and injections, etc. Once completed, the company should inspect the manufacturer’s certifications, including WHO, GMP, ISO, DCGI approvals, etc., to ensure compliance to quality standards.

Key Tip:

Choose a manufacturer with a good reputation and a balanced product portfolio, and balanced to ensure quality and timely delivery.

Step 2: Quotation and Cost Finalisation

The second phase of setting the product line is negotiating the price and determining the minimum order quantity.

The manufacturer’s quotation is influenced by:

• product composition
• batch size
• packaging type (blister, bottle, strip, etc.)
• raw material, and transportation cost
• Once the terms of prices are accepted, a purchase order (PO) is issued.

Step 3: Documentation and Legal Formalities

Third party manufacturing requires formal documentation. These documents:

• Company Profile
• Drug License
• GST Registration
• PAN Card
• Brand Name and Design Approval

The manufacturer verifies these documents before initiating production. This ensures the product is legally manufactured under the client’s brand name.

Step 4: Product Manufacturing and Quality Control

As soon as the necessary documents are in place, the manufacturer starts the initial stage of production while observing the Good Manufacturing Practices standards. Each stage of production, including the testing of raw materials up to the final packaging, is carefully scrutinised for quality and compliance, ensuring that the product’s safety, effectiveness, and purity are uncompromised.

Quality Control Includes:

• Raw Material Testing
• In-Process Quality Checks
• Final Product Testing (chemical & microbiological)

This stage helps in verifying that the product is in alignment with the standards set in the pharmaceutical industry and the specifications laid out by the DCGI.

Step 5: Packaging and Branding

Brand identity is strongly influenced by the design of packaging. Customised packaging is supplied by the manufacturer based on the design provided by the client, which includes:

• Brand Name
• Logo
• Batch Number
• Manufacturing & Expiry Dates
• MRP and Composition Details (what is in the product)

At this phase, the client provides final approval of the artistic elements and design of the packaging

Step 6: Delivery and Dispatch

All finished products that are properly packed and have passed all necessary tests are sent directly to the client or the client’s storage area for distribution.

This includes a batch analysis report and all other relevant documents.

At this stage, we have reached the end of our 3rd party manufacturing cycle, which includes all the steps necessary to go from a product idea to a marketed pharmaceutical product.

Advantages of Third Party Pharma Manufacturing

A third party manufacturer provides multiple advantages for pharma companies:

1. Cost Efficiency
   No investment in machinery or infrastructure means huge savings on setup and maintenance costs.
2. Time Efficiency
   Once the manufacturer handles production, the pharma business can just focus on the sales and marketing arms of the business.
3.  Scalability
   Uneasy scaling of the business without the production limitations is easy, as the third party manufacturer handles all production elements.
4. Quality Control
   No production levels of a business will be as consistent as a manufacturer that follows the WHO-GMP protocols.
5. Freedom
   A large variety of products can be narrowed down, as well, the pharma business can alter the make-up of a product based on market needs.

Why Work With WHO-GMP Certified Manufacturers?

Knowing a WHO-GMP certified pharma manufacturer is working provides:

• Assurance of compliance with global standard requirements
• Safe and effective product formulation
• Positive reputation with distributors and health care personnel

Impelled Remedies are well-established pharma businesses with a reputation for transparency and trust.

Conclusion

The third party pharma manufacturing process is a well-structured and efficient system that allows pharma companies to bring their products to market without heavy investment. From product selection to final dispatch, every step is designed to maintain quality, compliance, and customer satisfaction.

If you’re planning to expand your pharma business, partnering with a reputed third party manufacturer like Impelled Remedies can be your best strategic move toward success.