Molecules / Macitentan

Macitentan API manufacturers

CAS 441798-33-0 ATC C02KX04 Updated 9 July 2026
15
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$14979.71
median export price per kg $12698.30 to $16246.27 · 6 exporters · 2022
2
shortage records on file across 2 countries
272
finished-dose makers across 35 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Alembic Pharmaceuticals

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

Holds one active US DMF for macitentan, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 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 macitentan, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 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 macitentan, filing since 2017. 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

Honour Lab

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

Holds one active US DMF for macitentan, filing since 2017. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Zydus Lifesciences

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

Holds one active US DMF for macitentan, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Raks Pharma

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

Holds one active US DMF for macitentan, filing since 2016. 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
07

Apitoria Pharma

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

Holds one active US DMF for macitentan, filing since 2017. 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
09

Matrix Pharmacorp

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

Holds one active US DMF for macitentan, filing since 2016. 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
10

Seasons Biotechnology (Taizhou)

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

Holds one active US DMF for macitentan, filing since 2017. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Zhejiang Huayi Pharmaceutical

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

Holds one active US DMF for macitentan, 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
12

Lonza

Switzerland
Makes the API

Registered with SFDA (Saudi Arabia) for macitentan. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
4 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Zhejiang Lepu Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for macitentan. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

Zhejiang Ausun

China
Makes the API

Registered with SFDA (Saudi Arabia) for macitentan.

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 more manufacturers hold filings for macitentan

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

Honour LabZydus LifesciencesRaks PharmaApitoria PharmaZhejiang Guobang PharmaceuticalMatrix PharmacorpSeasons Biotechnology (Taizhou)Zhejiang Huayi PharmaceuticalLonzaZhejiang Xianfeng Technology GroupZhejiang Lepu PharmaceuticalZhejiang Ausun
Open the full list with a free account

Finished-dose makers (28)

Sandoz Switzerland Olpha Latvia Zentiva, k.s Czech Republic Hetero India Viatris United States Apotex Canada Patheon Italia Italy Torrent Pharmaceuticals India MSN Laboratories India Excella Gmbh Germany Aizant Drug Research Solutions India Macleods Pharmaceuticals India Patheon France S.A.S France STADA Arzneimittel Germany Janssen-Cilag Farmaceutica Ltda Brazil Laboratorio Elea Phoenix Argentina Nobel Ilac Sanayii Ve Ticaret Turkey AlRazi Pharmaceutical Industries Factory Saudi Arabia Laboratorios Bagó Argentina 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 2022. These are export values rather than contract prices for regulated-market grade material, which are higher.

Map macitentan for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Price history 1 yrs Shortages 2 Finished dose 28 Contract mfrs 0

By country

India 13 China 12