Suppliers / Rakshit Drugs

Rakshit Drugs

India Updated 9 July 2026

The public registers hold a second record for Rakshit Drugs. The fuller profile, with 10 active US DMFs and 8 valid CEPs, is at Rakshit Pharmaceuticals. Figures on this page cover only this record.

Rakshit Drugs is an API manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as VAI. Customs aggregates show $4.8M of exports covering 224 molecules to 29 destinations in 2025.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, 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

Filings and GMP by regulator

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

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $982K 15
2025 Not reported $4.8M 29
2024 Not reported $5.8M 29
2023 Not reported $5.6M 31

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 We do not publish the identity of any buyer.

Questions about Rakshit Drugs

Does Rakshit Drugs hold a US DMF or a CEP?
Rakshit Drugs holds 4 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 Rakshit Drugs FDA-registered?
One site operated by Rakshit Drugs 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 Drugs'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 Drugs manufacture?
1 registered site is on record, in India (Anakapalli). Every site is listed on this page with the register it came from.
What does Rakshit Drugs make?
5 molecules are on record against Rakshit Drugs, including Apixaban, Dapagliflozin, Leflunomide and Mirabegron. Each links through to that molecule's full manufacturer list.
Which regulators recognise Rakshit Drugs's GMP?
Current GMP certificates are on record from 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

  • The most recent inspection outcome was VAI, on 22 November 2024.

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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