Suppliers / Gufic Biosciences

Gufic Biosciences

India 2 duplicate records merged Updated 9 July 2026

Gufic Biosciences is an API and finished-dose manufacturer based in India. It appears in 70 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), CDSCO (India) and INVIMA (CO). Its GMP standing is certified by EMA, CDSCO (India) and NAFDAC (NG), among 6 authorities. Customs aggregates show $23.6M of exports covering 850 molecules to 67 destinations in 2025.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
70
filings across 9 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
Dhar, India 3043782814
GUJARAT, India Not on file
navsari, India Not on file
Navsari, India Not on file
kabilpore 396 424navsari navsari, India Not on file
Mumbai India, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Lidocaine SFDA (Saudi Arabia) 1
Miconazole SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Avibactam finished dose Aztreonam finished dose Caspofungin finished dose Dalbavancin finished dose Isavuconazonium finished dose Leuprolide finished dose Lidocaine API Miconazole API Semaglutide finished dose Tazobactam finished dose Teicoplanin finished dose Tigecycline finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 25 None
CDSCO (India) 15 4
INVIMA (CO) 10 None
MINSA (CR) 7 None
BOMRA (BW) 6 None
TMDA (TZ) 3 1
EMA None 5
NAFDAC (NG) None 2
ANVISA (Brazil) None 2
UZPHARM (UZ) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.3M 33
2025 Not reported $23.6M 67
2024 Not reported $19.3M 62
2023 Not reported $11.5M 57

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 We do not publish the identity of any buyer.

Questions about Gufic Biosciences

Does Gufic Biosciences hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Gufic Biosciences. It does have 70 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Gufic Biosciences FDA-registered?
One site operated by Gufic Biosciences 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 Gufic Biosciences manufacture?
6 registered sites are on record, in India and Nigeria (Dhar, Gujarat and Navsari among others). Every site is listed on this page with the register it came from.
What does Gufic Biosciences make?
2 molecules are on record against Gufic Biosciences, including Lidocaine and Miconazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gufic Biosciences's GMP?
Current GMP certificates are on record from EMA, CDSCO (India), NAFDAC (NG), ANVISA (Brazil), TMDA (TZ) and 1 more. 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. Gufic Biosciences comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Comparable suppliers

Olon shares 1 molecule Moehs shares 1 molecule Harman Finochem shares 1 molecule Quimica Sintetica shares 1 molecule Erregierre shares 1 molecule

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