Third-Party Manufacturing

PROCESS OF THIRD PARTY CONTRACT MANUFACTURING

Third Party Manufacturing business in the pharma industry is growing at very fast pace globally and is expected to increase at a very fast rate over the next few years. Every manufacturing business company is using quite similar technologies and equipment.

The third party manufacturing process consists of multiple steps, and for each step there are process parameters with some control limits.

  • Finalizing order quantity and composition
  • Raising quotation
  • Required documents
  • Packaging material
  • Product manufacturing
  • Product delivery

Frequently Asked Questions

What is Pharma CMO (contract manufacturing organization) ?

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overheads.

Generally, third-party manufacturing is a process of manufacturing medicines and products from other parties. In this process, signing an agreement is done between the company and the manufacturing company, and the manufacturing company manufactures the products as per the contract.

In third party manufacturing, there is no time compulsion to deliver the goods whereas contract manufacturing has delivery time compulsion. Mostly small companies work at the basis of third party manufacturing whereas medium size and big companies work at contract manufacturing basis

What is packing material for pharmaceutical/Ayurvedic products?

Packing material is outer covering in which dosage form is packed. It may in form of paper or plastic or rubber or tin or in other form. Packing material includes Outer cartoon, mono cartoon (if applicable), foil, label, lami tube etc. Generally vial, ampoule, protein powder tin, pet bottle don’t be considered in packing material but these are also the part of packing material. It is considered to be part of product. Manufacturer will give you rate including bottle, vial etc even if you will ask for rates without packing material. In pharmaceutical industry, there is norm that must be printed at packing material.

Query 1:

We are planning to start a Nutraceutical/ayurvedic marketing company and found your guidance very helpful. However, we have one doubt: if a product manufactured by a third party shows any adverse reaction, then who will be held responsible — the marketing company or the manufacturing company? Also, what kind of penalties could apply?

Response:

At Green Remedi Nutraceuticals & Extracts, every product is manufactured strictly in accordance with GMP, FSSAI, and ISO 22000:2018 standards (and under FDA license for Ayurvedic products & Nutraceutical Products under the license of FSSAI).

In general regulatory practice, the manufacturer is responsible for ensuring that each batch is produced using approved ingredients, standard formulations, and validated processes. These formulations are based on permitted Ayurvedic or nutraceutical combinations that have already undergone safety and stability evaluations.

However, if any adverse reaction or substandard quality issue is reported, the Drug Control Authority (DCGI/State FDA/AYUSH Department) may initiate an inquiry.

If the issue is due to manufacturing deviation or poor-quality production, the manufacturer will be held responsible.

The marketing company must provide proof of purchase, distribution, and sales records, and demonstrate that it was unaware of any quality deviations.

That said, the marketing company also shares ethical and commercial responsibility to ensure product quality by:

Obtaining a Certificate of Analysis (COA) from the manufacturer for every batch.

Maintaining proper documentation for product recall and complaint handling.

Ensuring that products are marketed as per approved label claims and dosage guidelines.

If the authority finds negligence or active involvement from the marketing side, both manufacturer and marketer can be held accountable. Penalties may include fines, suspension of license, or imprisonment, depending on the severity and regulatory category of the product involved.

Query 2:

Even if a manufacturing company has FDA approval for a product, what if the product is not manufactured as per the specified API strength, or it loses stability during its shelf life?
As a marketing company planning for contract manufacturing, how can we ensure the consistent quality and stability of our products?

Response:

This is a very valid and important question.
Even when products are approved and the manufacturer holds all licenses, batch-to-batch quality assurance remains critical.

As a marketing company partnering with Green Remedi Nutraceuticals & Extracts, you should follow these two essential steps to ensure quality and stability:

Obtain the Certificate of Analysis (COA)
Always request the COA for each batch you receive from the manufacturer. This certificate provides analytical details such as assay value, microbial limits, heavy metal testing, moisture content, and overall compliance with specifications.

Independent Laboratory Testing
For added assurance, you may send random samples of each batch to an independent NABL-accredited testing laboratory for verification. Such labs can perform assay, stability, and purity testing to confirm that the product maintains the specified API strength and complies with FSSAI or AYUSH standards.

Batch Documentation and Stability Data
Manufacturers like Green Remedi maintain stability studies, in-process control data, and validation reports for every product. You can request these as part of your contract manufacturing quality agreement.

By following these steps, both manufacturer and marketing partner maintain transparency and accountability — ensuring safe, stable, and compliant products throughout their market lifecycle

It Depends Upon Company As Well As Product Section , Its Varies Company To Company , Party Can Negotiate With Manufacturing Company .

Query:

Requesting your help regarding drug brand name registration I run a proprietorship company in Bangalore pcd business already but want to enter contract manufacturing. Companies are demanding brand Name Affidavits. I just want to clarify that

Response:

Companies demand brand name Affidavit for avoiding any future problem. In Pharma daily new molecule launch and companies has to search for a unique Trade Name/Brand Name for it. One most common way to search unique brand name to search at IP INDIA website and know whether your brand name is resembling to any other or not. But there is lot of brands available which are not applied for brand name registration. That can’t be searched by it. So, there is maximum chances, any new chosen trade name could clash with any already existing trade name.

Manufacturing companies will ask for brand name affidavit because they want to confirm that you are not using any other company brand name. You Brand Name/Trade Name is unique and don’t resemble to any other Brand Name/trade Name available in Market. If in Future your Brand Name will clash with any other Company’s Brand Name, you will have total responsibility for it. Manufacturing company will not bear any responsibility and expenditure with regard to this brand name.

If one company is marketing by Name of Sovamax, you can’t choose any Trade Name/Brand Name Similar or resembling to it like Aovamax. It will be offense under Intellectual Property Act. You have to choose different Name like Kdakmax etc. For entering into contract manufacturing, you should set-up your new marketing company and have to choose brand names for it.