Suppliers / Mylan Laboratories Limited [Otl]

Mylan Laboratories Limited [Otl]

India Updated 9 July 2026

Mylan Laboratories Limited [Otl] is a finished-dose manufacturer based in India. It appears in 46 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with MCAZ (ZW) and JFDA (JO). Its GMP standing is certified by ANVISA (Brazil).

0
active US DMFs
0
valid CEPs
2
registered plants
46
filings across 2 regulators

Registered plants

Site FDA FEI
Bangalore- 562105, United Arab Emirates Not on file
BANGALORE, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MCAZ (ZW) 38 None
JFDA (JO) 8 None
ANVISA (Brazil) None 2

Questions about Mylan Laboratories Limited [Otl]

Does Mylan Laboratories Limited [Otl] hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Mylan Laboratories Limited [Otl]. It does have 46 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Mylan Laboratories Limited [Otl] manufacture?
2 registered sites are on record, in United Arab Emirates and India (Bangalore- 562105 and Bangalore). Every site is listed on this page with the register it came from.
Which regulators recognise Mylan Laboratories Limited [Otl]'s GMP?
Current GMP certificates are on record from ANVISA (Brazil). 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