Suppliers / Genentech

Genentech

United States Updated 9 July 2026

Genentech is a finished-dose manufacturer based in United States. It appears in 1,415 regulatory filings across 29 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and MPA (SE). Its GMP standing is certified by ANSM (FR), US FDA and HSA (SG), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 21 April 2025 as NAI.

0
active US DMFs
0
valid CEPs
9
registered plants 3 with an FDA FEI number
1,415
filings across 29 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 confirmed
EU GMP
0 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 21 April 2025 NAI US FDA
  • 16 August 2024 NAI US FDA
  • 2 May 2024 VAI US FDA
  • 19 April 2024 VAI US FDA
  • 20 March 2024 NAI US FDA
  • 12 March 2024 VAI US FDA
  • 11 August 2023 VAI US FDA
  • 21 February 2023 NAI US FDA

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

Registered plants

Site FDA FEI
Indianapolis, United Arab Emirates Not on file
Mannheim, United Arab Emirates Not on file
Boulogne Billancourt, France Not on file
CASABLANCA, Morocco Not on file
Ota, Portugal Not on file
SOUTH SAN FRANCISCO, United States Not on file

3 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 192 None
EMA 162 1
MPA (SE) 129 None
FAMHP (BE) 125 None
INFARMED (PT) 125 None
US FDA 83 3
ANSM (FR) None 5
HSA (SG) None 2
ANVISA (Brazil) None 2
NCELS (KZ) None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 21 April 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates