Molecules / Nintedanib

Nintedanib API manufacturers

CAS 656247-17-5 ATC L01XE31 Updated 9 July 2026
16
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$2595.90
median export price per kg $1996.66 to $3352.54 · 10 exporters · 2025
3
shortage records on file across 2 countries
289
finished-dose makers across 38 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds one active US DMF for nintedanib, filing since 2021. 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
02

Biocon

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

Holds one active US DMF for nintedanib, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

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

Macleods Pharmaceuticals

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

Holds one active US DMF for nintedanib, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

MSN Laboratories

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

Holds 2 active US DMFs for nintedanib, filing since 2017. 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
05

Cipla

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

Holds one active US DMF for nintedanib, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

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

Alivus Life Sciences

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

Holds 2 active US DMFs for nintedanib, filing since 2017. 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
07

Glenmark Pharmaceuticals s.r.o

Czech Republic
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for nintedanib. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
08

Sichuan Kelun Pharmaceutical

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

Holds one active US DMF for nintedanib, filing since 2023. Its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 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 nintedanib, filing since 2019. 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
10

Fermion Oy

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

Holds 2 active US DMFs for nintedanib, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Formosa Laboratories

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

Holds 2 active US DMFs for nintedanib, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Olon

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

Holds 2 active US DMFs for nintedanib, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Shandong Anhong Pharmaceutical

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

Holds one active US DMF for nintedanib, filing since 2023. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Hubei Chengtian Pharmaceutical

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

Holds one active US DMF for nintedanib, filing since 2018. 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
16

Veranova Lp

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

Holds one active US DMF for nintedanib, filing since 2018.

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

13 more manufacturers hold filings for nintedanib

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

MSN LaboratoriesCiplaAlivus Life SciencesGlenmark Pharmaceuticals s.r.oSichuan Kelun PharmaceuticalJiangsu Hansoh Pharmaceutical GroupFermion OyFormosa LaboratoriesOlonShandong Anhong PharmaceuticalChongqing Huapont Shengchem PharmaceuticalHubei Chengtian PharmaceuticalVeranova Lp
Open the full list with a free account

Contract manufacturers (1)

Omgene Life Sciences India

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

Finished-dose makers (20)

Boehringer Ingelheim Pharma Gmbh Germany BDR Lifesciences India Catalent Germany Eberbach Germany Zentiva, k.s Czech Republic Viatris United States Dr. Reddy's Laboratories India Qilu Pharmaceutical China Sandoz Switzerland Jamp Pharma Canada Laboratorios Cinfa S A Spain STADA Arzneimittel Germany Boehringer Ingelheim Animal Health Usa United States Lotus Pharmaceutical Co Ltd Nantou Plant Taiwan Laboratorio Elea Phoenix Argentina Boston Oncology Arabia Saudi Arabia Genus Pharmaceuticals United Kingdom Laboratorio Stada S.L Spain TEVA Israel Eg S P A 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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 1 yrs Shortages 3 Finished dose 20 Contract mfrs 1

By country

China 10 India 9