Suppliers / Sai Life Sciences

Sai Life Sciences

India 2 duplicate records merged Updated 9 July 2026

Sai Life Sciences is an API manufacturer based in India. It holds 8 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 June 2024 as VAI. Customs aggregates show $44.7M of exports covering 1,901 molecules to 20 destinations in 2025.

8
active US DMFs
0
valid CEPs
5
registered plants 3 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 June 2024 VAI US FDA
  • 12 April 2024 VAI US FDA
  • 8 June 2018 VAI US FDA
  • 7 September 2016 NAI US FDA
  • 3 June 2016 VAI US FDA
  • 8 May 2013 VAI US FDA
  • 23 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
bidar 585 403, India Not on file
Hyderabad, India 3005301950
Hyderabad, India 3004602077
Bidar, India Not on file
Bidar, India 3006398900

What they file, and where

Molecule Regulators Docs
Dapsone US FDA 2
Doxercalciferol US FDA 2
Ibutilide US FDA 2
Paricalcitol US FDA 2
Bilastine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Bilastine API Calci contract manufacturing Dapsone contract manufacturing Doxercalciferol contract manufacturing Enzalutamide contract manufacturing Fexofenadine contract manufacturing Paricalcitol API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 2
US FDA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $23.1M 18
2025 Not reported $44.7M 20

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 We do not publish the identity of any buyer.

Questions about Sai Life Sciences

Does Sai Life Sciences hold a US DMF or a CEP?
Sai Life Sciences holds 8 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.
Is Sai Life Sciences FDA-registered?
3 sites operated by Sai Life Sciences 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 Sai Life Sciences's last inspection go?
The most recent inspection on record closed on 14 June 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Sai Life Sciences manufacture?
5 registered sites are on record, in India (Bidar 585 403, Hyderabad and Bidar among others). Every site is listed on this page with the register it came from.
What does Sai Life Sciences make?
5 molecules are on record against Sai Life Sciences, including Dapsone, Doxercalciferol, Ibutilide and Paricalcitol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sai Life Sciences's GMP?
Current GMP certificates are on record from CDSCO (India) and US FDA. 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

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 14 June 2024.

Comparable suppliers

Formosa Laboratories shares 2 molecules Alp Pharm Beijing shares 2 molecules Chongqing Huapont Pharmaceutical shares 2 molecules Macleods Pharmaceuticals shares 1 molecule Neuland Laboratories 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