Suppliers / Biofarma

Biofarma

Turkey Updated 9 July 2026

Biofarma is a finished-dose manufacturer based in Turkey. It appears in 90 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), INHRR (VE) and EEC_EAEU. Its GMP standing is certified by ANVISA (Brazil), NAFDAC (NG) and EMA. Customs aggregates show $264K of exports covering 3 molecules to 1 destination in 2025.

0
active US DMFs
0
valid CEPs
8
registered plants 1 with an FDA FEI number
90
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Mereto di Tomba, United Arab Emirates Not on file
Gallarate, United Arab Emirates Not on file
San Pietro Viminario, United Arab Emirates Not on file
Mereto di Tomba, United Arab Emirates Not on file
HORTOLÂNDIA, Brazil Not on file
Brazil, Brazil 3021095601

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 39 None
INHRR (VE) 34 None
EEC_EAEU 6 None
INFARMED (PT) 5 None
INVIMA (CO) 4 None
JFDA (JO) 1 None
ANVISA (Brazil) None 1
NAFDAC (NG) None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2025 Not reported $264K 1
2024 Not reported $920K 1
2023 Not reported $25K 1
2022 Not reported $11K 1

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 We do not publish the identity of any buyer.

Questions about Biofarma

Does Biofarma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Biofarma. It does have 90 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Biofarma FDA-registered?
One site operated by Biofarma 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.
Where does Biofarma manufacture?
8 registered sites are on record, in United Arab Emirates, Brazil, Italy and Nigeria (Mereto Di Tomba, Gallarate and San Pietro Viminario among others). Every site is listed on this page with the register it came from.
Which regulators recognise Biofarma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), NAFDAC (NG) and EMA. 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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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