Molecules / Carboplatin

Carboplatin API manufacturers

CAS 41575-94-4 ATC L01XA02 Updated 9 July 2026
12
manufacturers with an active filing 9 of them hold a US DMF or a CEP
63
shortage records on file across 9 countries
474
finished-dose makers across 50 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds one active US DMF and one valid CEP for carboplatin, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
02

Qilu Pharmaceutical

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

Holds one active US DMF and one valid CEP for carboplatin, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
7 markets
03

Laurus Labs

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

Holds 2 active US DMFs and one valid CEP for carboplatin, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
05

Cipla

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

Holds 4 valid CEPs for carboplatin, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced EDQM certificate database
View profile
06

Umicore Argentina

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

Holds one active US DMF for carboplatin, filing since 2014. Its 2018 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Heraeus Precious Metals GmbH

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

Holds one active US DMF for carboplatin, filing since 2000. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Veranova Lp

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

Holds one active US DMF for carboplatin, filing since 1987.

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
09

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for carboplatin. 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
10

Heraeus Deutschland GmbH

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for carboplatin. 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
11

Registered with PMDA (Japan) for carboplatin.

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
12

Strem Chemicals

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

Holds one active US DMF for carboplatin, filing since 2002. Its 2025 FDA inspection closed as OAI.

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

9 more manufacturers hold filings for carboplatin

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

Open the full list with a free account

Contract manufacturers (5)

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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