Suppliers / Azico Biophore India

Azico Biophore India

India Updated 9 July 2026

Azico Biophore India is an API manufacturer based in India. It holds 12 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with MINSA (CR) and CDSCO (India). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 5 September 2025 as VAI. Customs aggregates show $9.3M of exports covering 234 molecules to 36 destinations in 2025.

12
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 September 2025 VAI US FDA
  • 31 January 2019 NAI US FDA
  • 7 December 2015 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 3010823443

What they file, and where

Molecule Regulators Docs
Dapagliflozin US FDA 2
Levothyroxine SFDA (Saudi Arabia), US FDA 2
Pantoprazole US FDA 2
Empagliflozin US FDA 1
Famotidine US FDA 1
Isoprenaline SFDA (Saudi Arabia) 1
Liothyronine Sodium US FDA 1
Oseltamivir US FDA 1
Permethrin SFDA (Saudi Arabia) 1
Sildenafil US FDA 1
Show all 12 molecules on file
Tadalafil US FDA 1
Triclabendazole US FDA 1

Also appears on these molecule pages

Famotidine API Isoprenaline API Levothyroxine API Oseltamivir API Permethrin API Sildenafil API Tadalafil API Empagliflozin API Pantoprazole API Dapagliflozin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
CDSCO (India) 1 None
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.1M 18
2025 Not reported $9.3M 36
2024 Not reported $8.6M 32
2023 Not reported $7.6M 32

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 We do not publish the identity of any buyer.

Questions about Azico Biophore India

Does Azico Biophore India hold a US DMF or a CEP?
Azico Biophore India holds 12 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 Azico Biophore India FDA-registered?
One site operated by Azico Biophore India 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 Azico Biophore India's last inspection go?
The most recent inspection on record closed on 5 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Azico Biophore India 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 Azico Biophore India make?
12 molecules are on record against Azico Biophore India, including Dapagliflozin, Levothyroxine, Pantoprazole and Empagliflozin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Azico Biophore India'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.

Comparing suppliers?

Choose your molecules and target markets. Azico Biophore India comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 5 September 2025.

Comparable suppliers

Apitoria Pharma shares 4 molecules Dr Reddy's Laboratories shares 4 molecules Macleods Pharmaceuticals shares 4 molecules Hetero shares 3 molecules SMS Pharmaceuticals shares 3 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