API Suppliers & Manufacturers in India
Generic active pharmaceutical ingredients (APIs), drug-loaded pellets and excipients from manufacturers whose GMP certificates and regulatory files we check before you buy.
Choosing an API supplier is mostly about documents
India is one of the world's largest producers of generic APIs, and many molecules are made by several Indian manufacturers. Prices between them can be close. What separates a good supplier from a risky one is the regulatory file behind the API, the GMP standard of the site and how well the manufacturer controls changes over time.
For a registered medicine, the API source is part of the registration. A US ANDA usually references the API maker's Drug Master File; a European marketing authorisation usually relies on a CEP or an Active Substance Master File. Changing the API source later usually means a variation (a prior approval supplement in the US), new batch and stability data, and cost, so it pays to choose carefully the first time.
We work with API manufacturers rather than traders, and check that the documents fit your market before we quote.
Tell us this to get a quote
- API name and grade (USP, Ph. Eur., IP, JP or in-house)
- Quantity per order and per year
- Target market(s) and the registration the API will support
- Documents needed: US DMF, CEP, ASMF, written confirmation, WHO-GMP
- Special specifications: particle size, polymorph, salt form
- Sample needed for qualification?
- Required delivery date and packing
What to check in an API supplier
The regulatory file
A US Type II Drug Master File with a Letter of Authorization, a CEP from EDQM, or an Active Substance Master File for Europe; for other markets, the technical package your regulator accepts.
Written confirmation for the EU
APIs imported into the EU from India for human medicines need a written confirmation from CDSCO that the site follows GMP at least equivalent to EU GMP and is regularly inspected. Ask for a current copy that names the API you are buying.
GMP evidence
API manufacture should follow ICH Q7. Ask for the WHO-GMP certificate from the Indian regulator, any US FDA or EU inspection outcomes (EU outcomes are public in EudraGMDP) and, for a new supplier, an audit report.
Certificate of Analysis and specification
On the CoA: assay, related substances, residual solvents (ICH Q3C) and, where relevant, particle size and polymorph. Alongside it: elemental impurity data for your ICH Q3D assessment and a nitrosamine risk assessment.
Change control
A quality agreement requiring notice before any change of synthetic route, site, key starting material or specification.
Manufacturer or trader
The manufacturer's name and site address should appear on the CoA and match the DMF or CEP. Distributors must follow good distribution practice and, if based in the EU, be registered with their national authority. Companies that repack or relabel APIs count as manufacturers and must follow GMP.
Which API document does your market need?
| Document | What it is | Used for |
|---|---|---|
| US DMF (Type II) | Confidential API file held by the US FDA (never "approved"); the holder files a Letter of Authorization and sends you a copy | US generic and new drug applications |
| CEP | Certificate of Suitability from EDQM confirming that the Ph. Eur. monograph properly controls that manufacturer's API; not a GMP certificate or batch CoA | EU and many other markets that accept CEPs |
| ASMF | Active Substance Master File with an Applicant's Part for you and a Restricted Part for the regulator only | EU applications where the maker has no CEP |
| Written confirmation | Statement from the exporting country's regulator on GMP for APIs exported to the EU | Importing APIs into the EU |
| WHO-GMP certificate | GMP certificate issued by the Indian regulator (CDSCO with the State Licensing Authority) confirming compliance with WHO GMP guidelines | Many emerging markets and tenders |
| Certificate of Analysis | The manufacturer's test results for the specific batch | Every shipment |
Requirements differ by country and by product. We confirm what your regulator expects before you commit to a source.
APIs, pellets and granules we list
A selection of the APIs and drug-loaded pellets on PharmaTradz. Each page shows the grade and the finished brands it is used in; we confirm the manufacturer, documents and lead time for each enquiry.
See all active pharmaceutical ingredients and pharmaceutical excipients on PharmaTradz. Need several quotes fast? Our Smart Sourcing service handles a full sourcing request for a fixed fee.
Guides for API buyers
How it works with PharmaTradz
You send the API, grade, quantity, target market and the documents you need.
Two or three manufacturing sites, not traders, that make the API to your grade and hold the documents your market requires. Names under a confidential disclosure agreement when the requirement is firm.
Certificate of Analysis, the Applicant's Part of the ASMF, the DMF holder's open part for US filings or a copy of the CEP, GMP evidence and a sample for your laboratory.
Your QA reviews the documents and tests the sample, with a site audit where needed. A quality agreement covers change control, and the manufacturer provides a Letter of Authorization (US DMF) or letter of access (EU ASMF or CEP) for your registration.
Orders with a batch-wise Certificate of Analysis from the manufacturer.
Scheduled orders from the same site, with notice of any change to the route, site or starting materials.
Problems we see most often
A trader's CoA with the maker removed
Some traders re-issue certificates without the manufacturer's name, so the API cannot be traced to a registered site. Insist on the original manufacturer's CoA.
Letter of Authorization delays
Your registration stalls while waiting for the DMF holder to issue the Letter of Authorization, pay the US DMF fee or update its file. Agree the timing before the first order.
Unannounced process changes
A new route or starting-material source changes the impurity profile. A quality agreement with change notification prevents surprises.
Looking for an API?
Send the API, grade, quantity and target market. We will tell you which manufacturers fit and what documents they hold.
Send your requirement Talk to our teamRelated services
Making finished products too? See white label and third-party manufacturing, or the CDMO and contract manufacturing guide hub.
