Molecules / Lurbinectedin

Lurbinectedin API manufacturers

CAS 497871-47-3 Updated 9 July 2026
8
manufacturers with an active filing 8 of them hold a US DMF or a CEP
9
finished-dose makers across 9 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Pharma Mar

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

Holds one active US DMF for lurbinectedin, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

MSN Laboratories

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

Holds one active US DMF for lurbinectedin, filing since 2024. 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

Natco Pharma

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

Holds 2 active US DMFs for lurbinectedin, filing since 2024. 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
04

Wisdom Pharmaceutical

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

Holds one active US DMF for lurbinectedin, filing since 2023. 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
05

Apicore Pharmaceuticals

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

Holds one active US DMF for lurbinectedin, 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
06

Chongqing Sintaho Pharmaceutical

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

Holds one active US DMF for lurbinectedin, filing since 2026. 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
07

BrightGene Bio-Medical Technology

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

Holds one active US DMF for lurbinectedin, 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
08

Xiling Lab

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

Holds one active US DMF for lurbinectedin, filing since 2024.

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

5 more manufacturers hold filings for lurbinectedin

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

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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