Suppliers / Mylan Laboratories Ltd. (Unit-7)

Mylan Laboratories Ltd. (Unit-7)

India 3 duplicate records merged Updated 9 July 2026

Mylan Laboratories Ltd. (Unit-7) is an API manufacturer based in India. Its GMP standing is certified by MFDS (Korea) and EMA.

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

Registered plants

Site FDA FEI
Andhra Pradesh, India Not on file

What they file, and where

Molecule Regulators Docs
Fluconazole SFDA (Saudi Arabia) 1
Loratadine SFDA (Saudi Arabia) 1
Valaciclovir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Fluconazole API Loratadine API Valaciclovir API Valacyclovir API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
EMA None 2

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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