Molecules / Bosutinib

Bosutinib API manufacturers

CAS 380843-75-4 ATC L01XE14 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
$6057.67
median export price per kg $3695.18 to $11871.46 · 10 exporters · 2023
4
shortage records on file across 2 countries
147
finished-dose makers across 31 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 3 active US DMFs for bosutinib, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
3 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
02

Hetero

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

Holds one active US DMF for bosutinib, filing since 2024. 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
View profile
03

Alembic Pharmaceuticals

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

Holds one active US DMF for bosutinib, filing since 2016. 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
View profile
05

Esteve Química

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for bosutinib. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

2 more manufacturers hold filings for bosutinib

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

Alp Pharm BeijingEsteve Química
Chat with Fred, your AI analyst

Contract manufacturers (1)

Lgm Pharma United States

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

Finished-dose makers (17)

Dr. Reddy's Laboratories India Zentiva, k.s Czech Republic Pfizer Brasil Ltda Brazil Hospira United States Pfizer United States Excella Gmbh Germany MSN Laboratories India Sandoz Switzerland STADA Arzneimittel Germany BDR Lifesciences India TEVA Israel Laboratorios Synthesis, S.A.S Colombia Eg S P A Italy Laboratorio Stada S.L Spain Jazeera Pharmaceutical Industries Saudi Arabia Laboratorio Eczane Pharma Argentina Pfizer Canada Ulc Canada

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
Price band
Customs export unit values for 2023. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes bosutinib?

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

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Also on this molecule

Price history 1 yrs Shortages 4 Finished dose 17 Contract mfrs 1