Sourcing

Sourcing APIs from China and India: what to verify

The checks that separate a reliable API supplier from an expensive mistake.

In short

China and India supply a large share of the world's active pharmaceutical ingredients. The central risk is that the same market contains manufacturers, legitimate traders and intermediaries presenting themselves as manufacturers. Verification means confirming which site produced the batch, that the quality certification belongs to that site, and that documentation still matches at shipment rather than only at quotation.

China and India between them supply a large share of the world's active pharmaceutical ingredients. The range is enormous and the pricing is competitive, which is why buyers go there. The difficulty is that the same market contains genuine manufacturers, legitimate trading companies, and intermediaries who present themselves as manufacturers. Telling them apart from a website and an email address is close to impossible, which is why verification matters more here than almost anywhere else in procurement.

Establish what you are actually dealing with

The first question is whether your counterparty makes the material or buys it. There is nothing wrong with buying through a trader, and traders serve a real purpose, but you need to know which one you are dealing with because it changes what they can guarantee and what documentation they control.

A manufacturer can tell you which site produced a batch. A trader often cannot, and if the site is unknown to you, the quality certification you have been shown may belong to somebody else entirely.

The documentation to insist on

Ask for the certificate of analysis for the specific batch, not a generic example. Ask which manufacturing site produced it. Ask for the quality certification held by that site, and check that the name on it matches. Where your destination market requires additional regulatory documentation, establish early whether the supplier can produce it, because retrofitting this after an order is placed is rarely possible.

Check the certificate against the shipment, not just the offer

Documentation that was accurate at quotation is not automatically accurate at shipment. Sites change, certifications lapse, and a supplier under pressure to fill an order may substitute material from a different source. Verification before shipment is what catches this, and it is the step buyers most often skip because everything looked fine earlier.

The economics of the shortcut. A rejected consignment costs the purchase price, the freight, the storage, the delay to whatever depended on it, and the cost of starting again. Measured against that, verification is cheap. Almost every serious sourcing failure we see traces back to a check that was skipped because the price was good.

Language and distance are part of the problem

A lot of what goes wrong in cross border sourcing is not dishonesty, it is ambiguity. A specification understood one way in the enquiry and another way at the factory produces material that is technically what was ordered and practically unusable. Being able to have that conversation directly, in the supplier's language, removes a category of problem that no amount of paperwork solves.

This is the work behind our API sourcing service. If you want to understand certification standards more broadly first, our guide to CE, FDA and SFDA covers what each one does and does not tell you.

Frequently asked questions

How do I know if a supplier is a manufacturer or a trader?

Ask which manufacturing site produced a specific batch. A manufacturer can answer. A trader frequently cannot, and if the site is unknown to you the quality certification shown may belong to another party entirely.

Is documentation checked at quotation enough?

No. Documentation accurate at quotation is not automatically accurate at shipment. Sites change, certifications lapse, and a supplier under pressure may substitute material from another source. Verification before shipment is the step most often skipped.

What is the real cost of a rejected consignment?

The purchase price, the freight, the storage, the delay to whatever depended on it, and the cost of starting again. Measured against that, verification is inexpensive.

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Written by

Dr. Majjid A. Qaria

Dr. Qaria holds two doctorates and a postdoctoral research background in the medical sciences, across molecular microbiology and cancer cell biology. He has personally sourced and supplied active pharmaceutical ingredients and excipients, and leads sourcing and consultancy at NJMC from Nanjing. Research background and publications are on his profile site.

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