Molecules / Ribociclib

Ribociclib API manufacturers

CAS 1211441-98-3 ATC L01XE42 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
6
shortage records on file across 4 countries
47
finished-dose makers across 35 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 APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for ribociclib, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
2 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

Alembic Pharmaceuticals

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

Holds one active US DMF for ribociclib, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

Cipla

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

Holds one active US DMF for ribociclib, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for ribociclib, filing since 2021. 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
05

Valary Lab

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

Holds 3 active US DMFs for ribociclib, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
3 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 ribociclib

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

Chunghwa Chemical Synthesis & BiotechValary Lab
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Contract manufacturers (3)

Chunghwa Chemical Synthesis & Biotech Taiwan Omgene Life Sciences India Suanfarma Spain

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

Finished-dose makers (4)

Novartis Switzerland Advanced Accelerator Applications France Sandoz Switzerland Novartis Farmacéutica, S. A Spain

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 ribociclib?

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

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Also on this molecule

Shortages 6 Recalls 2 Finished dose 4 Contract mfrs 3