Molecules / Carfilzomib

Carfilzomib API manufacturers

CAS 868540-17-4 ATC L01XX45 Updated 9 July 2026
20
manufacturers with an active filing 17 of them hold a US DMF or a CEP
87
finished-dose makers across 38 regulators
Showing 19 of 20 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Laurus Labs

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

Holds 2 active US DMFs for carfilzomib, filing since 2016. 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
02

MSN Laboratories

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

Holds one active US DMF for carfilzomib, filing since 2015. 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

Hetero

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

Holds one active US DMF for carfilzomib, 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
View profile
04

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 carfilzomib, filing since 2016. 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
05

Qilu Pharmaceutical

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

Holds one active US DMF for carfilzomib, 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

Shandong New Time Pharmaceutical

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

Holds one active US DMF for carfilzomib, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Biophore India Pharmaceuticals

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

Holds one active US DMF for carfilzomib, filing since 2017. 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
08

Chongqing Carelife Pharmaceutical

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

Holds one active US DMF for carfilzomib, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
09
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carfilzomib, filing since 2025. 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
View profile
10

Sichuan Huiyu Pharmaceutical

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

Holds one active US DMF for carfilzomib, filing since 2024. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Wisdom Pharmaceutical

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

Holds one active US DMF for carfilzomib, filing since 2025. 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
View profile
12
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carfilzomib, filing since 2025. 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
13

Chongqing Sintaho Pharmaceutical

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

Holds one active US DMF for carfilzomib, filing since 2025. 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
14

Polymed Therapeutics

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

Holds one active US DMF for carfilzomib, filing since 2016. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Jiangsu Xidi Pharmaceuticals

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

Holds one active US DMF for carfilzomib, 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
18

Cambridge Major Laboratories

United States
Makes the API

Registered with SFDA (Saudi Arabia) for carfilzomib.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Helsinn Advanced Synthesis

Switzerland
Makes the API

Registered with SFDA (Saudi Arabia) for carfilzomib.

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

Contract manufacturers (3)

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

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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