Suppliers / Mylan Pharmaceuticals

Mylan Pharmaceuticals

United States 6 duplicate records merged Updated 9 July 2026

Mylan Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 1,610 regulatory filings across 19 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), AIFA (IT) and US FDA. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 18 August 2023 as NAI. Customs aggregates show $64K of exports covering 1 molecule to 1 destination in 2024.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
1,610
filings across 19 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 August 2023 NAI US FDA
  • 26 May 2022 VAI US FDA
  • 9 November 2018 NAI US FDA
  • 7 November 2018 NAI US FDA
  • 1 March 2018 NAI US FDA
  • 18 November 2016 VAI US FDA
  • 24 April 2015 VAI US FDA
  • 13 March 2015 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Steinhausen, Switzerland Not on file
Steinhausen, Switzerland Not on file
CASABLANCA, Morocco Not on file
SAN CARLOS, United States Not on file
Morgantown, United States 1110315

Filings and GMP by regulator

Regulator Filings GMP certificates
SWISSMEDIC (CH) 437 None
AIFA (IT) 305 None
US FDA 289 1
FAMHP (BE) 238 None
MEDSAFE (NZ) 153 None
INFARMED (PT) 38 None
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2024 Not reported $64K 1
2023 Not reported $908K 5
2022 Not reported $3.3M 14

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 We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was NAI, on 18 August 2023.

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