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

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 We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 February 2020.

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