Suppliers / Rusan Pharma

Rusan Pharma

India 865 employees Updated 9 July 2026

Rusan Pharma is an API and finished-dose manufacturer based in India. It holds 4 active US drug master files and 10 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with UZPHARM (UZ), RAMA (GE) and DAV (Vietnam). Its GMP standing is certified by CDSCO (India), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 3 May 2024 as VAI. Customs aggregates show $25.4M of exports covering 473 molecules to 47 destinations in 2025.

4
active US DMFs
10
valid CEPs
12
registered plants
65
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 3 May 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
Kutch 370230, United Arab Emirates Not on file
DEHRADUN, India Not on file
ate ankleshwarankleshwar 393 002 bharuch, India Not on file
Mumbai, India Not on file
Gidc, India Not on file
GUJARAT, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM 2
Eflornithine US FDA 2
Fentanyl EDQM 2
Nalmefene US FDA 2
Apomorphine EDQM 1
Bisoprolol EDQM 1
Diazepam EDQM 1
Methadone EDQM 1
Naloxone EDQM 1
Naltrexone EDQM 1

Also appears on these molecule pages

Amitriptyline finished dose Bisoprolol API Bromhexine finished dose Buprenorphine API Diazepam API Fentanyl API Methadone API Naloxone API Naltrexone API Nicotine contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 41 None
RAMA (GE) 5 None
DAV (Vietnam) 5 None
CDSCO (India) 3 5
MCAZ (ZW) 2 None
MINSA (CR) 2 None
ANVISA (Brazil) None 5
EMA None 4
NCELS (KZ) None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.4M 8
2025 Not reported $25.4M 47
2024 Not reported $29.8M 47
2023 Not reported $20.7M 50

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 We do not publish the identity of any buyer.

Questions about Rusan Pharma

Does Rusan Pharma hold a US DMF or a CEP?
Rusan Pharma holds 4 active US drug master files and 10 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.
How did Rusan Pharma's last inspection go?
The most recent inspection on record closed on 3 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Rusan Pharma manufacture?
12 registered sites are on record, in United Arab Emirates and India (Kutch 370230, Dehradun and Ate Ankleshwarankleshwar 393 002 Bharuch among others). Every site is listed on this page with the register it came from.
What does Rusan Pharma make?
10 molecules are on record against Rusan Pharma, including Buprenorphine, Eflornithine, Fentanyl and Nalmefene. Each links through to that molecule's full manufacturer list.
Which regulators recognise Rusan Pharma's GMP?
Current GMP certificates are on record from CDSCO (India), ANVISA (Brazil), EMA, NCELS (KZ) 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

  • The most recent inspection outcome was VAI, on 3 May 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