Suppliers / Srini Pharmaceuticals

Srini Pharmaceuticals

India 15 employees 2 duplicate records merged Updated 9 July 2026

Srini Pharmaceuticals is an API manufacturer based in India. It holds 11 active US drug master files and 7 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 18 October 2019 as NAI. Customs aggregates show $19.4M of exports covering 264 molecules to 29 destinations in 2025.

11
active US DMFs
7
valid CEPs
4
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
5 of 5 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 18 October 2019 NAI US FDA
  • 27 October 2017 NAI US FDA
  • 24 April 2015 VAI US FDA
  • 19 July 2012 NAI US FDA
  • 2 April 2009 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Visakhapatnam, India 3042718107
Choutuppal, India Not on file
Nalgonda, India 3004015257
Bhongiri, India Not on file

What they file, and where

Molecule Regulators Docs
Labetalol EDQM, SFDA (Saudi Arabia), US FDA 3
Amlodipine SFDA (Saudi Arabia), US FDA 2
Dextromethorphan EDQM, US FDA 2
Esomeprazole EDQM, US FDA 2
Hydroxychloroquine SFDA (Saudi Arabia), US FDA 2
Levetiracetam EDQM, US FDA 2
Omeprazole EDQM, US FDA 2
Pregabalin EDQM, US FDA 2
Rivaroxaban EDQM, US FDA 2
Apixaban US FDA 1
Show all 12 molecules on file
Dabigatran Etexilate US FDA 1
Levofloxacin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Amlodipine API Dabigatran Etexilate API Dextromethorphan API Esomeprazole API Hydroxychloroquine API Labetalol API Levetiracetam API Omeprazole API Pregabalin API Rivaroxaban API Levofloxacin API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.5M 9
2025 Not reported $19.4M 29
2024 Not reported $16.3M 29
2023 Not reported $11.6M 30

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 We do not publish the identity of any buyer.

Questions about Srini Pharmaceuticals

Does Srini Pharmaceuticals hold a US DMF or a CEP?
Srini Pharmaceuticals holds 11 active US drug master files and 7 valid CEPs. 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.
Is Srini Pharmaceuticals FDA-registered?
2 sites operated by Srini Pharmaceuticals carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Srini Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 18 October 2019 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Srini Pharmaceuticals manufacture?
4 registered sites are on record, in India (Visakhapatnam, Choutuppal and Nalgonda among others). Every site is listed on this page with the register it came from.
What does Srini Pharmaceuticals make?
12 molecules are on record against Srini Pharmaceuticals, including Labetalol, Amlodipine, Dextromethorphan and Esomeprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Srini Pharmaceuticals's GMP?
Current GMP certificates are on record from EMA. 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.

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Open risk flags

  • The most recent inspection outcome was NAI, on 18 October 2019.

Comparable suppliers

Dr Reddy's Laboratories shares 8 molecules Zydus Lifesciences shares 7 molecules Hetero shares 6 molecules Alivus Life Sciences shares 6 molecules Apitoria Pharma shares 5 molecules

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