Suppliers / Panacea Biotec Pharma

Panacea Biotec Pharma

India 3 employees 2 duplicate records merged Updated 9 July 2026

Panacea Biotec Pharma is a finished-dose manufacturer based in India. It appears in 104 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with TMDA (TZ), ARCSA (EC) and JFDA (JO). Its GMP standing is certified by EMA, NAFDAC (NG) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 12 October 2023 as OAI. Customs aggregates show $15.2M of exports covering 482 molecules to 43 destinations in 2025.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
104
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 12 October 2023 OAI US FDA
  • 8 June 2022 OAI US FDA
  • 30 April 2019 NAI US FDA
  • 13 December 2017 VAI US FDA
  • 11 December 2015 VAI US FDA
  • 25 October 2013 VAI US FDA
  • 7 September 2012 NAI US FDA
  • 13 November 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Baddi, United Arab Emirates Not on file
Solan, India 3007187282
BADDI, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
TMDA (TZ) 29 None
ARCSA (EC) 14 None
JFDA (JO) 11 None
UZPHARM (UZ) 9 None
MINSA (CR) 8 None
DAV (Vietnam) 7 None
EMA None 3
NAFDAC (NG) None 1
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2025 Not reported $15.2M 43
2024 Not reported $17.4M 41
2023 Not reported $19.5M 35
2022 Not reported $15.1M 36

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 We do not publish the identity of any buyer.

Questions about Panacea Biotec Pharma

Does Panacea Biotec Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Panacea Biotec Pharma. It does have 104 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Panacea Biotec Pharma FDA-registered?
One site operated by Panacea Biotec 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 Panacea Biotec Pharma's last inspection go?
The most recent inspection on record closed on 12 October 2023 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 2 closed as OAI.
Where does Panacea Biotec Pharma manufacture?
3 registered sites are on record, in United Arab Emirates and India (Baddi, Solan and Baddi). Every site is listed on this page with the register it came from.
Which regulators recognise Panacea Biotec Pharma's GMP?
Current GMP certificates are on record from EMA, NAFDAC (NG) and ANVISA (Brazil). 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 OAI, on 12 October 2023.

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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