Drug APIs

Active pharmaceutical ingredient sourcing

We source APIs from manufacturers in China and India, and we assess them the way a formulator would: impurity profile, polymorphic form, particle size and the regulatory file behind them.

In short

NJMC Medical Supplies sources active pharmaceutical ingredients from manufacturers in China and India for buyers in China, Yemen, the Middle East and the United Kingdom. APIs are assessed on impurity profile, polymorphic form, particle size distribution and regulatory documentation before price is discussed. NJMC is a sourcing and consultancy company, not a manufacturer.

Most API sourcing goes wrong for one of two reasons. Either the material is not what the paperwork claims, or the paperwork itself will not survive contact with the regulator in the importing country. Both are avoidable, and avoiding them is technical work rather than commercial work.

That is the distinction this business is built on. A trading desk compares offers. We read the certificate of analysis against the specification, ask which site actually manufactured the batch, and check whether the regulatory file supports the filing you intend to make.

What we assess before an API is offered to you

Price is the last question, not the first. Before that:

  • Impurity profile. Named and unspecified impurities against your specification, and whether the supplier can hold that profile across batches rather than in one favourable lot.
  • Polymorphic form. The wrong polymorph can be chemically identical and pharmaceutically useless. It has to be stated, and it has to be controlled.
  • Particle size distribution. Relevant wherever dissolution or content uniformity matters, and a common cause of a material passing on paper and failing in the blend.
  • Residual solvents and elemental impurities. Assessed against ICH Q3C and Q3D expectations for the destination market.
  • Nitrosamine risk. Now a standing question for many molecules, and one a serious manufacturer will already have an answer to.
  • The manufacturing site. Not the trading company on the letterhead. The site named on the GMP certificate has to be the site making your material.

Regulatory documentation

What you need depends on where you are filing. We establish that before shortlisting, because retrofitting a document package after an order is placed is rarely possible.

DocumentWhat it does for you
Certificate of AnalysisBatch specific results against the agreed specification. Ask for the batch, not a specimen.
GMP certificateConfirms the manufacturing site operates under a recognised quality system. Check the site address and the expiry.
Drug Master FileSupports a filing without exposing the manufacturer's confidential process to you.
CEP, where it existsCertificate of suitability to the European Pharmacopoeia. Strong evidence, and easy to verify independently.
Stability dataSupports shelf life and storage claims, and is often the gap in a package that otherwise looks complete.

Therapeutic areas

Sourcing is done to your specification rather than from a fixed catalogue, which means the practical limit is what can be manufactured to standard and documented properly, not what happens to be in stock.

A note on what NJMC is. We are a sourcing and consultancy company, not a manufacturer. We do not own production facilities and we do not represent a single factory. That independence is the point: it means a shortlist reflects what fits your specification rather than what we hold.

How we work

  1. Specification. Molecule, grade, pharmacopoeial standard, quantity, destination market and the filing you intend to support.
  2. Shortlist. Manufacturers whose site certification and regulatory file match that destination, not simply those who quote fastest.
  3. Documentation review. We collect and read the package before it reaches you, and tell you where it is thin.
  4. Samples. Arranged where the manufacturer provides them, so your own analysis confirms the paper.
  5. Quotation. With terms set out, so options are genuinely comparable.
  6. Verification before shipment. Confirming that what ships matches the documentation you approved.

Markets

We work with buyers in China, Yemen, the wider Middle East and the United Kingdom. Requirements differ by market, and a certificate that satisfies one regulator will not always satisfy another.

Frequently asked questions

Does NJMC manufacture active pharmaceutical ingredients?

No. NJMC is a sourcing and consultancy company. We do not own production facilities and we do not represent a single factory, which is what allows a shortlist to reflect your specification rather than our inventory.

What documentation can you obtain for an API?

Depending on the manufacturer and your filing route, this can include a batch specific certificate of analysis, the GMP certificate for the manufacturing site, a Drug Master File with letter of access, a CEP where one exists, and stability data. We establish what your destination market requires before shortlisting.

Why does polymorphic form matter when buying an API?

A different polymorph can be chemically identical and pharmaceutically unusable, because solubility and dissolution behaviour change. The form has to be stated on the specification and controlled by the manufacturer, not assumed.

Which markets does NJMC supply?

China, Yemen, the wider Middle East and the United Kingdom. Requirements differ by market and a certificate accepted by one regulator will not always satisfy another.

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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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Tell us what you need to source

Send the product or molecule, the grade, the quantity and the destination market. You will get a considered answer about what can be sourced and what documentation comes with it.

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