Third party manufacturing, also called contract manufacturing, is the arrangement under which a pharma marketing company or brand owner has its medicines made at a licensed manufacturing plant owned by another company. The brand owner holds the brand and the market. The manufacturer holds the plant, the manufacturing licence and the quality system, and makes the products to the approved formulation under an agreed scope, specification and quality responsibility.
Who uses third party manufacturing
Pharma marketing companies, including PCD franchise companies, that sell under their own brand names without owning a plant. Brand owners adding products to a range without investing in new capacity. Institutional and tender suppliers who need pharmacopoeial products made to a specification with certificates of analysis. Exporters who need a WHO-GMP manufacturing source and the manufacturer’s documents for a registration file abroad.
Why companies choose it
A product can be launched without building a plant. Portfolio expansion is faster because the manufacturer already holds approvals for a wide range of formulations. Capital stays with sales and distribution rather than with buildings, machines and licences. Quality control, stability studies and documentation come from a plant that runs them every day.
What the manufacturer provides
Manufacturing under its own licence, with the manufacturer’s name, plant address and licence number printed on the pack as the Drugs Rules require. Quality control testing and batch release from its own laboratory. A certificate of analysis with every batch. Stability data on request. Printed packaging to the brand owner’s approved artwork. For exports, the manufacturer’s documents on the importing regulator’s checklist.
What the brand owner needs
A wholesale drug licence (Form 20B and 21B) from the state drug controller to buy and sell the finished products, a GST registration, and a trademark application for each brand name. The brand name is checked for similarity with existing names before printing, as required under Rule 96 of the Drugs Rules. The manufacturing licence stays with the manufacturer; a loan licence, where the licence stands in the brand owner’s own name at the manufacturer’s plant, is a separate arrangement.
How an engagement runs
The brand owner sends the products and strengths, pack sizes, annual quantity and, if ready, the artwork. The manufacturer checks feasibility against its licence and product list and sends a written proposal with rate, batch size, pack format, payment terms and lead time. Artwork is finalised and proofs are approved. The batch is manufactured, packed in printed foil and cartons, tested and released by quality control, and dispatched with its certificate of analysis. At Vibcare Healthcare the lead time is 45 to 60 days from the day the artwork is finalised.
What to check before choosing a manufacturer
Which dosage forms the manufacturing licence covers. The installed capacity of each section and how much of it is free. Whether foil and cartons are printed inside the plant. Whether the quality control laboratory is on site and certified, and whether the plant runs its own stability studies. What documents arrive with each batch. Who owns and operates the plant. What the lead time is counted from. Who answers a query on a batch. Then visit the plant.
Frequently asked questions
Why manufacture in India? India has a large base of WHO-GMP certified plants, trained pharmacists and chemists, and manufacturing costs lower than most Western markets, and Indian plants supply regulated and semi-regulated markets across the world.
Which certifications should a manufacturer hold? A valid manufacturing licence from the state drug controller covering the dosage forms in question, a WHO-GMP certificate for the site, and a certified quality control laboratory. ISO 9001 covers the management system, not the medicines.
How long does manufacturing take? It depends on the dosage form, pack and batch size, and on whether the product is already on the manufacturer’s licence. A manufacturer should state the lead time in writing and say what it is counted from.
What is the minimum order? One batch per product. The batch size for each product and section is stated in the proposal.
Can the same manufacturer make tablets, capsules, liquids and creams? Only if its licence and plant cover all four sections. Vibcare Healthcare’s plant at Dabkori, Panchkula has all four.
For Vibcare Healthcare’s capacities, machines, laboratory, documents and lead time, see Third Party Pharma Manufacturing Company in India.
