Suppliers / Biophore India Pharmaceuticals

Biophore India Pharmaceuticals

India 672 employees Updated 9 July 2026

Biophore India Pharmaceuticals is an API and finished-dose manufacturer based in India. It holds 152 active US drug master files. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 26 April 2024 as NAI. Customs aggregates show $9.7M of exports covering 225 molecules to 34 destinations in 2025.

152
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
10
filings across 2 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

  • 26 April 2024 NAI US FDA

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

Registered plants

Site FDA FEI
Visakhapatnam, India 3015941740

What they file, and where

Molecule Regulators Docs
Prochlorperazine US FDA 3
Asciminib US FDA 2
Cariprazine US FDA 2
Cladribine US FDA 2
Diatrizoate US FDA 2
Eliglustat US FDA 2
Etacrynic Acid US FDA 2
Iron Sucrose US FDA 2
Melphalan US FDA 2
Naphazoline US FDA 2
Show all 30 molecules on file
Olaparib US FDA 2
Phylloquinone US FDA 2
Suvorexant US FDA 2
Tafamidis US FDA 2
Tolvaptan US FDA 2
Triethylenetetramine US FDA 2
Viloxazine US FDA 2
Acrivastine US FDA 1
Alosetron US FDA 1
Aminocaproic Acid US FDA 1
Ataluren US FDA 1
Avatrombopag US FDA 1
Belinostat US FDA 1
Bempedoic Acid US FDA 1
Bendamustine US FDA 1
Bilastine US FDA 1
Bortezomib US FDA 1
Brexpiprazole US FDA 1
Calcium US FDA 1
Cannabidiol US FDA 1

Also appears on these molecule pages

Show 80 more molecule pages
Cetrorelix API Chlorpromazine contract manufacturing Chlorzoxazone API Cladribine contract manufacturing Clofarabine API Clomipramine API Crisaborole API Cysteamine API Dantrolene API Decitabine contract manufacturing Diazoxide contract manufacturing Dimethyl API Docosanol contract manufacturing Edaravone API Edoxaban API Elagolix contract manufacturing Eliglustat contract manufacturing Eltrombopag API Ertugliflozin API Erythromycin API Favipiravir API Fluorescein API Fluphenazine API Fosaprepitant API Gadobutrol contract manufacturing Gadoteric Acid API Icatibant contract manufacturing Indapamide API Indocyanine Green API Isavuconazonium API Isoprenaline API Isosulfan Blue API Isotretinoin contract manufacturing L-Glutamine API Letermovir API Levothyroxine contract manufacturing Mavacamten API Melphalan contract manufacturing Metolazone API Mexiletine API Molnupiravir finished dose Nadolol contract manufacturing Naphazoline API Nelarabine contract manufacturing Nimodipine API Niraparib API Nitazoxanide API Obeticholic Acid API Olaparib API Palbociclib contract manufacturing Penicillamine API Permethrin API Phylloquinone API Pimavanserin API Pitolisant API Plerixafor contract manufacturing Primidone API Prucalopride contract manufacturing Ramelteon API Regadenoson contract manufacturing Resmetirom API Riociguat API Ruxolitinib API Safinamide API Selenious Acid API Selexipag API Sugammadex API Suvorexant API Tafamidis API Tavaborole API Terazosin API Tetraferric Tricitrate Decahydrate API Tipiracil contract manufacturing Tolvaptan API Tretinoin contract manufacturing Triethylenetetramine API Trifluridine contract manufacturing Valsartan API Viloxazine API Zileuton contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 8 None
MINSA (CR) 2 None
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.7M 17
2025 Not reported $9.7M 34
2024 Not reported $5.3M 31
2023 Not reported $5.2M 20

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

Questions about Biophore India Pharmaceuticals

Does Biophore India Pharmaceuticals hold a US DMF or a CEP?
Biophore India Pharmaceuticals holds 152 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 Biophore India Pharmaceuticals FDA-registered?
One site operated by Biophore India 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 Biophore India Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 26 April 2024 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Biophore India Pharmaceuticals manufacture?
1 registered site is on record, in India (Visakhapatnam). Every site is listed on this page with the register it came from.
What does Biophore India Pharmaceuticals make?
30 molecules are on record against Biophore India Pharmaceuticals, including Prochlorperazine, Asciminib, Cariprazine and Cladribine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Biophore India Pharmaceuticals'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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 26 April 2024.

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