The pharmaceutical industry is growing at an incredible pace, making it highly competitive, and third party pharma manufacturing is becoming a favored model of business. This model allows companies to focus on marketing and distribution while outsourcing the production to specialized manufacturers. It also helps to save costs and improve operational efficiency. Prior to engaging in third party manufacturing, it’s necessary to understand the entire process. In this blog, we will provide you a Process of third party pharma manufacturing step by step.
What is Third Party Pharma Manufacturing?
Also referred to as contract manufacturing or third party pharma manufacturing is when a pharmaceutical company delegates the production of one or all of its medicines to a different company. The outsourcing company’s brand name is applied to the product and the manufacturer is obliged to meet quality as well as other regulatory standards
Step-by-Step Process of Third Party Pharma Manufacturing
Step 1: Selecting a Reliable Third Party Manufacturer
The first and most important step is selecting a trustworthy third party pharma manufacturer. Factors you should consider include:
- Experience in the industry and overall reputation
- Relevant certification (WHO-GMP, ISO, DCGI approval, etc.)
- Product range as well as production capabilities
- Quality standards for assurance
- Scope for regulatory compliance
Step 2: Product Selection and Finalization
After you select a manufacturer, the next step is to determine what products you will have them manufacture. When selecting products, keep the following in mind:
- Competition and demand in the market
- Expected profits
- How the product works, as well as its formulation
Step 3: Requesting a Quotation
Once you have selected the products, the next step is to file a proposal with the manufacturer. The gross product quote usually consists of:
- Cost of product per each item
- MOQ (Minimum order quantity)
- Charges related to the label and package
- Production and Delivery time estimates
Step 4: Finalizing Documents and Signing of Agreements
For both parties to have a clear path forward, it is necessary for both parties to the manufacturing agreement to sign it. The pertinent documents are:
- Profile of Company and GST documents
- Permit to Deal in Drug (Wholesaler/Retailer)
- NOC if it applies
- Agreement on stated price, conditions and terms of sale
Step 5: Packaging That Needs Approval and Design
pharmaceuticals are strictly controlled as to the form in which they put them on the market. Design and approval of the following
- Brand name and logo
- Labeling information (composition, batch number, expiry date, etc.)
- Package inserts and promotional materials
- Bottle, blister, or strip packaging as required
Step 6: Initiation of Manufacturing Process
After all approvals are done, the manufacturer can commence production. Processes included in this stage are:
- Purchasing of raw materials and active pharmaceutical ingredients (APIs)
- Production under Good Manufacturing Practice (GMP) regulations
- Quality checks at all levels (raw material, in-process, and finish good)
Step 7: Quality Control and Testing
A significant focus should be placed on pharmacovia safety by ensuring that all high-quality standards are met. The manufacturer does a variety of tests such as:
- Assay and impurity evaluation
- Stability studies
- Microbial and sterility evaluation
If the product meets quality tests, it is authorized for packaging.
Step 8: Product Packaging and Labeling
During this stage, the product is accurately packed and labeled per the provided specification after quality approval. Packaging must be:
- Tamper resistant and regulatory compliant
- Properly marked with batch number, expiry date, and manufacturer details
Step 9: Final Inspection and Dispatch
The last steps before shipment involves the comprehensive assessment of the goods for:
- Ascertaining all items are in the required packaging
- Verification of each item’s label
- Ensuring the quality standards have been met
- Quality Assurance will now allow the products to be dispatched to the client’s designated area.
Step 10: Marketing and Distribution
Once you receive the products, you can start marketing and distributing them under your brand. Focus on:
- Promotional strategies and online presence
- Distribution through wholesalers, retailers, and medical representatives
- Compliance with marketing regulations
Choose Aenor Pharmaceuticals for best Third Party Manufacturing Company in India
Are you looking for a trusted third party pharma manufacturer? Aenor Pharmaceuticals is one of the leading third party pharma manufacturing companies in India. With years of expertise, state-of-the-art facilities, and a commitment to quality, Aenor Pharmaceuticals provides top-notch manufacturing solutions tailored to your needs. Get in touch with us to start your journey today!
