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 EMA and MFDS (Korea).

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
EMA None 2
MFDS (Korea) None 2

Questions about Mylan Laboratories Ltd. (Unit-7)

Where does Mylan Laboratories Ltd. (Unit-7) manufacture?
1 registered site is on record, in India (Andhra Pradesh). Every site is listed on this page with the register it came from.
What does Mylan Laboratories Ltd. (Unit-7) make?
3 molecules are on record against Mylan Laboratories Ltd. (Unit-7), including Fluconazole, Loratadine and Valaciclovir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mylan Laboratories Ltd. (Unit-7)'s GMP?
Current GMP certificates are on record from EMA and MFDS (Korea). 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