Molecules / Baloxavir Marboxil

Baloxavir Marboxil API manufacturers

CAS 1985606-14-1 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
27
finished-dose makers across 26 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for baloxavir marboxil, filing since 2022. 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
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02

Porton Pharma Solutions

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

Holds one active US DMF for baloxavir marboxil, filing since 2024. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Changzhou Pharmaceutical Factory

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

Holds 3 active US DMFs for baloxavir marboxil, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Sinopep-Allsino Biopharmaceutical

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

Holds one active US DMF for baloxavir marboxil, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for baloxavir marboxil

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

Sinopep-Allsino BiopharmaceuticalSuzhou Ryway Biotech
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Finished-dose makers (3)

Genentech United States Hoffmann-La Roche Switzerland F.Hoffmann-La Roche Switzerland

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 baloxavir marboxil?

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

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Also on this molecule

Finished dose 3 Contract mfrs 0