FAQ’S

CMO is defined as the process of outsourcing the work of manufacturing or producing medication like tablets and capsules for third party consumption.This process may involve drug development processes and even regulatory support to help with the approvals required for a drug to release in the market.

The benefits are :-

  • Use of advanced skills
  • Global outreach
  • Cost effectiveness
  • Quality assurance

Third party manufacturing pharmaceutical products is redistributing pharma products or having products manufactured from other manufacturing unit with your own brand names on it.

The benefits are as follows :-

  • Best quality products to associates.
  • Cost effective process that proves pharma manufacturing reasonable & pocket friendly.
  • Consistency in supply and providing supply much in advance before specified timelines.
  • Helps to build goodwill for business, as well as products.
  • Also, allows expansion of the business.

Third party manufacturing and contract manufacturing is the base of the pharmaceutical sector. As the demand for medicines is rising and to meet such increasing requirements, manufacturing companies are the only ones that can fulfill the demand.

Third party manufacturingis when a pharmaceutical company gets medicines produced with its own brand name at a decided quantity at a specified time from a manufacturing company. Mostly, small to medium size companies opt for third party manufacturing services. In this, the manufacturing company does not have any kind of condition or time compulsion.

Contract manufacturing is done when a pharmaceutical company gets medicines manufactured at some customized condition, like requesting to provide raw material, packaging material and other product related requirement. A legal dealing wherein the company manufacturer commits to provide the product on the decided date. Mostly, big size companies deploycontract manufacturing, hence provides technical insight to the pharmaceutical companies.

Selecting contract manufacturing or third-party manufacturing is totally influenced by the particular requirements of the company. As it becomes extremely challenging for pharma companies to carry out all operations single handedly, the most economical idea is collaboration with contract or outside pharma companies. They can be involved in a number of activities ranging from production & packaging of products to testing and further development of products as well.

Basically, packing material is the outer covering in which dosage is packed. It may be in the form of paper, plastic, tin or rubber. Packing material includes – outer carton, mono carton, foil, label, lami tube etc. Type:- 1.BOX, 2 FOIL, 3.LABEL, 4.LAMI TUBE, 5.INNER/MONO CARTON.

There are two ways of procurement :-

  • Directly involve in printing of packing material, or
  • Let the manufacturer procure it themselves. In this, the manufacturer will give you rate at third party basis with or without packing material. Inventory requirement generally depends on the cost of the product. Inventory may vary from product to product or from dosage to dosage. Packing material costs a major portion of inventory. For certain products, it may be more than the total cost of the batch. So, prices of the inventory may vary.

Quality is the main aspect that needs to be taken into account for a third party manufacturing company.

  • The company should carry its large scale production in its state art manufacturing facilities.
  • Manufacturing facilities be fully integrated with latest technology and equipment enabling to produce quality medicine.
  • Manufacturing should produce only drug controlled & approved tablets(molecules).
  • Testing of each batch at the labs for quality and efficacy of the product.
  • Third party manufacturing companies should possess WHO- GMP certification indicating the necessary infrastructure and equipment to create safe and effective pharma goods that fulfill quality requirements.
  • An experienced third party manufacturing company would promise affordability along-with quality. A third party manufacturer with experience definitely lays its focus on unmatched quality of its products.
  • Third party manufacturing should carry its operations in compliance to the approvals of the FDA to ensure high quality of its products.

The MOQ can be 500 boxes

  • For injections    2000 Unit
  • For syrup    2000 Bottles

The general MOQ is 1,00,000 for Tablet/Capsule. If the product is costlier, it could be 30,000 to 50,000 tablet per batch. For the liquid range, most small pharma manufacturing MOQ is 2,000 to 5,000 pieces.

Companies demand affidavit or Trade name from 3rd Party Manufacturing to avoid any future problems

  • To avoid any brand name clashes by another company
  • A unique brand name/trade name ensures authority and responsibility
  • Duplicity is offensive under the Intellectual Property Act.