Suppliers / Raks Pharma

Raks Pharma

India Updated 9 July 2026

Raks Pharma is an API manufacturer based in India. It holds 72 active US drug master files. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 29 August 2025 as NAI. Customs aggregates show $3.4M of exports covering 19 molecules to 3 destinations in 2025.

72
active US DMFs
0
valid CEPs
3
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 August 2025 NAI US FDA
  • 24 January 2020 VAI US FDA
  • 13 February 2015 NAI US FDA
  • 19 September 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Anakapalli, India 3008250894
Dahej, India Not on file
dahejbharuc h 392 130, India Not on file

What they file, and where

Molecule Regulators Docs
Abiraterone SFDA (Saudi Arabia), US FDA 2
Azathioprine US FDA 2
Dexlansoprazole US FDA 2
Doxycycline US FDA 2
Esomeprazole US FDA 2
Metyrosine SFDA (Saudi Arabia), US FDA 2
Omeprazole US FDA 2
Prochlorperazine US FDA 2
Tramadol US FDA 2
Apremilast US FDA 1
Show all 30 molecules on file
Atazanavir US FDA 1
Atorvastatin US FDA 1
Bosentan US FDA 1
Brexpiprazole US FDA 1
Calcium US FDA 1
Carvedilol US FDA 1
Celecoxib US FDA 1
Chlordiazepoxide US FDA 1
Chlorpromazine US FDA 1
Citalopram US FDA 1
Clidinium US FDA 1
Clobazam US FDA 1
Clopidogrel US FDA 1
Colestipol US FDA 1
Dapagliflozin US FDA 1
Darunavir US FDA 1
Doxepin US FDA 1
Dronedarone US FDA 1
Eliglustat US FDA 1
Eltrombopag US FDA 1

Also appears on these molecule pages

Show 46 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $296K 1
2025 Not reported $3.4M 3
2024 Not reported $3.7M 4
2023 Not reported $3.8M 5

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 We do not publish the identity of any buyer.

Questions about Raks Pharma

Does Raks Pharma hold a US DMF or a CEP?
Raks Pharma holds 72 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 Raks Pharma FDA-registered?
One site operated by Raks Pharma 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 Raks Pharma's last inspection go?
The most recent inspection on record closed on 29 August 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Raks Pharma manufacture?
3 registered sites are on record, in India (Anakapalli, Dahej and Dahejbharuc H 392 130). Every site is listed on this page with the register it came from.
What does Raks Pharma make?
30 molecules are on record against Raks Pharma, including Abiraterone, Azathioprine, Dexlansoprazole and Doxycycline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Raks Pharma'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

  • 4 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 29 August 2025.

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