Molecules / Bortezomib

Bortezomib API manufacturers

CAS 179324-69-7 ATC L01XX32 Updated 9 July 2026
19
manufacturers with an active filing 19 of them hold a US DMF or a CEP
39
shortage records on file across 10 countries
697
finished-dose makers across 52 regulators
Showing 19 of 19 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

“Reliance Life Sciences

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

Holds one active US DMF for bortezomib, filing since 2012. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 13 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Dr. Reddy's Laboratories

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

Holds one active US DMF for bortezomib, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

Laurus Labs

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

Holds 2 active US DMFs for bortezomib, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Hetero

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

Holds one active US DMF for bortezomib, filing since 2016. 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
05

Qilu Pharmaceutical

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

Holds one active US DMF for bortezomib, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

MSN Laboratories

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

Holds 2 active US DMFs for bortezomib, filing since 2013. 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
View profile
07

Granules India

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

Holds 2 active US DMFs for bortezomib, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Natco Pharma

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

Holds 2 active US DMFs for bortezomib, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Shilpa Pharma Lifesciences

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

Holds 2 active US DMFs for bortezomib, filing since 2011. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Biophore India Pharmaceuticals

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

Holds one active US DMF for bortezomib, filing since 2015. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Apicore

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

Holds one active US DMF for bortezomib, filing since 2009. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Jiangsu Hansoh Pharmaceutical Group

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

Holds one active US DMF for bortezomib, filing since 2018. Its GMP is recognised in 4 markets.

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

ScinoPharm Taiwan

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

Holds one active US DMF for bortezomib, filing since 2011. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for bortezomib, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 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
16

Gland Pharma

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

Holds one active US DMF for bortezomib, filing since 2012.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Hubei Honch Pharmaceutical

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Arthur Group

China
Makes the API

Holds one active US DMF for bortezomib, filing since 2023. 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
19

Shivalik Rasayan

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

Holds one active US DMF for bortezomib, filing since 2021.

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

16 more manufacturers hold filings for bortezomib

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

HeteroQilu PharmaceuticalMSN LaboratoriesGranules IndiaNatco PharmaSeacross Pharma (Europe)Shilpa Pharma LifesciencesBiophore India PharmaceuticalsApicoreJiangsu Hansoh Pharmaceutical GroupScinoPharm TaiwanHainan Shuangcheng PharmaceuticalsGland PharmaHubei Honch PharmaceuticalArthur GroupShivalik Rasayan
Open the full list with a free account

Contract manufacturers (11)

Biophore India Pharmaceuticals India Shilpa Pharma Lifesciences India Qilu Pharmaceutical China Viwit Pharmaceutical China Icrom Italy Lgm Pharma United States Dexa Medica Indonesia TBD Pharmatech Estonia Beijing Sunho Pharmaceutical China Dcs Pharma Usa 2 Switzerland Onko İlaç Sanayi̇ Veti̇caret A.Ş Turkey

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

Finished-dose makers (81)

Fresenius Kabi Ab Sweden Apotex Canada Pharmascience Canada Amneal United States HIKMA ITALIA Italy Gland Pharma India Pfizer Brasil Ltda Brazil Zydus Lifesciences India Naprod Life Sciences India Taro Pharmaceuticals Israel Viatris United States Oncomed Manufacturing Czech Republic Deva Holding Turkey Glenmark Pharmaceuticals s.r.o Czech Republic Zentiva, k.s Czech Republic Marksans Pharma India Teva Israel Medac Gesellschaft für klinische Spezialpräparate mbH; Germany STADA Arzneimittel Germany Bsp Pharmaceuticals Italy

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

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Also on this molecule

Shortages 39 Recalls 3 Finished dose 81 Contract mfrs 11

By country

India 19 China 10