Molecules / Vismodegib

Vismodegib API manufacturers

CAS 879085-55-9 ATC L01XX43 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
27
finished-dose makers across 24 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
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02

MSN Laboratories

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Synthon

Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2025. Its GMP is recognised in 14 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Zydus Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Zaklady Farmaceutyczne Polpharma

Poland
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2026. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Mehta Api

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for vismodegib, filing since 2026. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

3 more manufacturers hold filings for vismodegib

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Zydus LifesciencesZaklady Farmaceutyczne PolpharmaMehta Api
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Contract manufacturers (3)

Shilpa Pharma Lifesciences India Omgene Life Sciences India Polpharma Group Poland

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (4)

Genentech United States Hoffmann-La Roche Switzerland Patheon Canada DEVA HOLDİNG A.Ş. (2020/3) (Hammadde) Turkey

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes vismodegib?

Ask Fred which manufacturers are on record for vismodegib and what filings they hold.

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Also on this molecule

Recalls 1 Finished dose 4 Contract mfrs 3