Suppliers / Rakshit Pharmaceuticals

Rakshit Pharmaceuticals

India 156 employees reconciled across 2 public records · 2 entities Updated 9 July 2026

Rakshit Pharmaceuticals is an API manufacturer based in India. It holds 10 active US drug master files and 8 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA, EDQM and EMA. Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as VAI. Customs aggregates show $8.1M of exports covering 401 molecules to 37 destinations in 2025.

10
active US DMFs
8
valid CEPs
5
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 22 November 2024 VAI 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 3016246945
Vishakhapatnam, India Not on file
Anakapalli District, India Not on file
Anakapalli, India Not on file
Visakhapatnam, India Not on file

What they file, and where

Molecule Regulators Docs
Azathioprine EDQM, SFDA (Saudi Arabia), US FDA 3
Mycophenolate Mofetil EDQM, US FDA 2
Mycophenolic Acid EDQM, US FDA 2
Pantoprazole EDQM, SFDA (Saudi Arabia) 2
Sildenafil EDQM, SFDA (Saudi Arabia) 2
Tadalafil EDQM, SFDA (Saudi Arabia) 2
Apixaban US FDA 1
Avanafil US FDA 1
Dapagliflozin US FDA 1
Diacerein EDQM 1
Show all 14 molecules on file
Famotidine EDQM 1
Leflunomide US FDA 1
Mirabegron US FDA 1
Vardenafil US FDA 1

Also appears on these molecule pages

Avanafil API Azathioprine API Diacerein API Famotidine API Mycophenolate Mofetil API Mycophenolic Acid API Sildenafil API Vardenafil API Pantoprazole API Tadalafil API

Filings and GMP by regulator

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

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.5M 19
2025 Not reported $8.1M 37
2024 Not reported $10.0M 34
2023 Not reported $13.3M 38

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 We do not publish the identity of any buyer.

Questions about Rakshit Pharmaceuticals

Does Rakshit Pharmaceuticals hold a US DMF or a CEP?
Rakshit Pharmaceuticals holds 10 active US drug master files and 8 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 Rakshit Pharmaceuticals FDA-registered?
One site operated by Rakshit Pharmaceuticals 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 Rakshit Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 22 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Rakshit Pharmaceuticals manufacture?
5 registered sites are on record, in India (Anakapalli, Vishakhapatnam and Anakapalli District among others). Every site is listed on this page with the register it came from.
What does Rakshit Pharmaceuticals make?
14 molecules are on record against Rakshit Pharmaceuticals, including Azathioprine, Mycophenolate Mofetil, Mycophenolic Acid and Pantoprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Rakshit Pharmaceuticals's GMP?
Current GMP certificates are on record from US FDA, EDQM and 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 22 November 2024.

Comparable suppliers

Dr Reddy's Laboratories shares 3 molecules Raks Pharma shares 3 molecules SMS Pharmaceuticals shares 3 molecules Zaklady Farmaceutyczne Polpharma shares 3 molecules Apitoria Pharma shares 2 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