For healthcare brands, stockists and franchise owners all over India, outsourcing production of pharmaceuticals has become a popular growth strategy. Collaborating with a specialized Third Party Manufacturer in India can help a business to grow its product line without spending multi-crores in sterile plant infrastructure, machine maintenance or regulatory compliance teams.
From creating a new gynaecology line to expanding a wellness line or developing general health formulations, the onboarding process is a crucial step in ensuring smooth execution from formulation approval to final shipment.
What Is Third Party Pharma Manufacturing?
It is a commercial agreement in which a brand entrusts the entire manufacturing of its formulations to a WHO-GMP qualified manufacturing unit. The contract partner is responsible for raw material procurement, batch processing, quality testing and completed packaging under your registered brand name.
The model allows your teams to concentrate on the sales network and doctor detailing, while also making use of the existing technology of the factory to manufacture special dosage forms such as softgel capsules, tablets, liquid syrups, etc.
Step-by-Step Process of Working with a Manufacturer
Step-by-Step Contract Manufacturing Process
1. Selection & Formulations
First, pick the exact dosage forms your market needs, whether that is standard tablets, hard capsules or softgels. There are pre-set catalog compositions or you can request custom formulations. Be sure to review the minimum order quantities for each product line prior to ordering.
2. Quotation & Costing
Then, obtain an honest quote from the manufacturer. There should be a breakdown of the cost of the raw active materials, primary foil packing (Alu-Alu or PVC) outer carton, the cost of the batch testing and the cost of GST (goods and services tax) so there are no surprises later on.
3. Documentation & Licensing
Prior to production you must lawfully comply by sharing your business data. Submit a copy of your current Wholesale License, 15-digit certificate of registration of the Goods and Services Tax, trademark brand registration documentation, and signed manufacturing agreement.
4. Branding & Foil Design
Now your packaging gets designed. Collaborate with the design team to review and finalize blister foil designs, logo placement and color branding.
5. Batch Production
After designs have received approval, actual manufacturing will take place under cleanroom conditions. The first step is to test raw materials to ensure their purity before they are filled into softgels, capsules, or tablets. Production teams monitor the integrity of the shells, shell fill weight and disintegration rate during the production process.
6. Quality Testing & Dispatch
Lastly, the finished batch is subjected to laboratory tests, and receives a Certificate of Analysis that certifies product’s purity, and dissolution standards. Once it goes through quality inspection it is loaded in heavy-duty shipping containers and sent directly to your warehouse.
Key Benefits of Partnering with an Established Plant
- Capital Savings: Avoids multi crore plant set-up, climate control maintenance and equipment upgrade costs.
- Quicker Product Launches: Pre-validated production lines enable new brands to get to the market shelves in weeks as opposed to months.
- Scalable Batch Capacity: Flexible batch capacity to meet seasonal market demand, without running out of stock.
Conclusion
Picking a reliable Third Party Manufacturer in India offers your business the foundation for expansion. With Indorama Pharma, you can leverage the facilities and high-grade softgel and tablet production lines that are all WHO GMP certified, as well as custom packaging solutions and end-to-end contract manufacturing support.
When you work with an experienced 3rd party manufacturer you can offer doctors and stockists consistent quality and develop a viable, valuable healthcare brand.
FAQ’s
Q1: Which is the top third party pharma manufacturing company in India?
Ans: Indorama Pharma is a renowned company that provides WHO-GMP certified facilities, a broad range of tablets, syrups and softgels and complete contract manufacturing service.
Q2: Which documents are needed to deal with Third Party Manufacturers in India?
Ans: The requirements are that you must have a valid Wholesale Drug License, 15-Digit GST Registration, Approved Brand Names and Manufacture Agreement signed.
Q3: What is the mean holding time of a new third-party batch?
Ans: Initial production runs will be 30 – 45 days after packaging design and foil approval, and repeat orders will be faster at 20 – 25 days.
Q4: What’s the typical MOQ of softgel capsules?
Ans: The custom foil printing, and packaging setup costs at most contract manufacturing plants start at 30,000 to 50,000 capsules.
Q5: Is a Certificate of Analysis (COA) provided with every batch by the manufacturer?
Ans: All completed batches are provided with an official COA confirming the active purity, fill uniformity and disintegration requirements prior to dispatch.