Suppliers / Sterile India

Sterile India

India 126 employees Updated 9 July 2026

Sterile India is an API manufacturer based in India. It holds 11 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by MFDS (Korea) and CDSCO (India). Customs aggregates show $11.4M of exports covering 249 molecules to 23 destinations in 2025.

11
active US DMFs
0
valid CEPs
0
registered plants
1
filings across 1 regulators

What they file, and where

Molecule Regulators Docs
Pantoprazole SFDA (Saudi Arabia), US FDA 2
Acyclovir US FDA 1
Ampicillin US FDA 1
Azithromycin US FDA 1
Ceftriaxone US FDA 1
Cefuroxime US FDA 1
Esomeprazole US FDA 1
Meropenem US FDA 1
Omeprazole US FDA 1
Piperacillin US FDA 1
Show all 11 molecules on file
Rabeprazole US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 1 1
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.6M 14
2025 Not reported $11.4M 23
2024 Not reported $11.3M 20
2023 Not reported $6.9M 17

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Sterile India

Does Sterile India hold a US DMF or a CEP?
Sterile India holds 11 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
What does Sterile India make?
11 molecules are on record against Sterile India, including Pantoprazole, Acyclovir, Ampicillin and Azithromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sterile India's GMP?
Current GMP certificates are on record from MFDS (Korea) and CDSCO (India). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

Comparing suppliers?

Choose your molecules and target markets. Sterile India comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Comparable suppliers

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts