Suppliers / Hiral Labs

Hiral Labs

India Updated 9 July 2026

Hiral Labs is a finished-dose manufacturer based in India. It appears in 63 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and DIGEMAPS (DO). Its GMP standing is certified by NAFDAC (NG) and UZPHARM (UZ).

0
active US DMFs
0
valid CEPs
2
registered plants
63
filings across 8 regulators

Registered plants

Site FDA FEI
Uttarakhand, United Arab Emirates Not on file
ROORKEE, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 35 None
UZPHARM (UZ) 15 1
DIGEMAPS (DO) 3 None
NAFDAC (NG) 3 2
FDA (GH) 3 None
EDE (AE) 2 None

Questions about Hiral Labs

Does Hiral Labs hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hiral Labs. It does have 63 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Hiral Labs manufacture?
2 registered sites are on record, in United Arab Emirates and Nigeria (Uttarakhand and Roorkee). Every site is listed on this page with the register it came from.
Which regulators recognise Hiral Labs's GMP?
Current GMP certificates are on record from NAFDAC (NG) and UZPHARM (UZ). 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