Suppliers / Saraca Laboratories

Saraca Laboratories

India Updated 9 July 2026

Saraca Laboratories is an API manufacturer based in India. It holds one active US drug master file and 4 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 14 February 2020 as VAI. Customs aggregates show $2.5M of exports covering 64 molecules to 16 destinations in 2025.

1
active US DMFs
4
valid CEPs
4
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 14 February 2020 VAI US FDA
  • 11 December 2015 NAI US FDA
  • 14 February 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Gaddapotharam Village, India Not on file
Srikakulam, India Not on file
Hyderabad, India Not on file
Sangareddy, India 3004641543

What they file, and where

Molecule Regulators Docs
Gabapentin EDQM, US FDA 2
Ranitidine EDQM, SFDA (Saudi Arabia) 2
Pantoprazole EDQM 1
Pregabalin EDQM 1

Also appears on these molecule pages

Gabapentin API Ranitidine API Pantoprazole API Pregabalin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $620K 8
2025 Not reported $2.5M 16
2024 Not reported $3.7M 17
2023 Not reported $2.2M 14

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 We do not publish the identity of any buyer.

Questions about Saraca Laboratories

Does Saraca Laboratories hold a US DMF or a CEP?
Saraca Laboratories holds 1 active US drug master file and 4 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 Saraca Laboratories FDA-registered?
One site operated by Saraca Laboratories carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Saraca Laboratories's last inspection go?
The most recent inspection on record closed on 14 February 2020 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Saraca Laboratories manufacture?
4 registered sites are on record, in India (Gaddapotharam Village, Srikakulam and Hyderabad among others). Every site is listed on this page with the register it came from.
What does Saraca Laboratories make?
4 molecules are on record against Saraca Laboratories, including Gabapentin, Ranitidine, Pantoprazole and Pregabalin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Saraca Laboratories'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 VAI, on 14 February 2020.

Comparable suppliers

Solara Active Pharma Sciences shares 2 molecules Apitoria Pharma shares 1 molecule Hetero shares 1 molecule Dr Reddy's Laboratories shares 1 molecule Olon shares 1 molecule

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