FDA DMF Approved API Manufacturer for the US Market
Sixty-plus active US FDA Type II Drug Master Files. Same-day Letter of Authorization for ANDA, IND, NDA, and 505(b)(2) submissions. Audit-ready CMC packages, agreed deviations, and ICH-compliant stability data — manufactured under WHO-GMP in Pune, India.
How buying from a DMF-holder helps your FDA submission
A US Drug Master File lets a generic sponsor reference an API manufacturer’s confidential CMC data in their own ANDA without filing that data themselves. The sponsor only needs the manufacturer to issue a Letter of Authorization (LoA) identifying their DMF by number and granting reference rights.
For procurement and regulatory affairs teams, that means:
- Shorter ANDA review cycles — FDA reviews the DMF in parallel with the ANDA. If the DMF is already in “adequate” status, your ANDA reviewer doesn’t bottleneck on CMC.
- Lower regulatory burden — your team writes the drug-product CMC; ours owns the API CMC. Your filing is leaner.
- Confidentiality — our manufacturing trade secrets stay in our DMF, never visible to your sponsor file.
- Single-source defence — many sponsors qualify a second source pre-emptively. Listing us as Source-2 in your ANDA gives you a working backup if Source-1 stumbles.
Our DMF coverage
We currently hold 60+ active Type II DMFs spanning cardiovascular, anti-infective, oncology, CNS, and metabolic disorder APIs, plus key intermediates. Each DMF is annually updated and routinely cross-referenced by multiple US sponsors.
To see whether the specific molecule you need has an active DMF, browse the Human APIs catalogue and check the regulatory documentation tab on the product page, or contact our regulatory affairs team with the INN or CAS number.
How to request a Letter of Authorization
- Confirm the API you need is in our catalogue (or contact us about custom synthesis).
- Sign a supply agreement (or place a qualifying first order).
- Provide your sponsor company name, ANDA / IND number (or a placeholder), and the FDA submission gateway address.
- We issue the LoA on company letterhead, signed by the QA Head, within 24 business hours.
The LoA references the DMF number, the API name and Type, the sponsor company, and grants reference rights for the duration of the supply relationship.
Explore the catalogue
Frequently asked questions
Do you have an active US agent?
Yes. Our designated US Agent on FDA submissions is registered with FDA under the same DMF and contactable for all FDA correspondence. Their contact details appear on every LoA we issue.
Will FDA accept our ANDA citing your DMF before issuing the GDUFA fee?
Yes. The GDUFA Type II DMF fee for each of our DMFs has already been paid and the DMF is “Active.” You only pay your own ANDA fee — the DMF is already in good standing.
What about a Pre-Approval Inspection (PAI)?
Our Pune facility hosts FDA pre-approval inspections regularly. The most recent inspection closed without 483 observations. We provide PAI readiness packages including aseptic-area training records, equipment qualification, and validation reports.
Can you supply API to a US 503B outsourcing facility?
Yes — multiple US 503B compounders buy from us under bulk-API agreements. We can supply USP-grade material under their FD&C Act §503B sourcing requirements.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.