Molecules / Eltrombopag

Eltrombopag API manufacturers

CAS 496775-61-2 ATC B02BX05 Updated 9 July 2026
22
manufacturers with an active filing 21 of them hold a US DMF or a CEP
$5987.58
median export price per kg $5254.58 to $6994.96 · 15 exporters · 2025
8
shortage records on file across 5 countries
391
finished-dose makers across 42 regulators
Showing 20 of 22 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 2 active US DMFs for eltrombopag, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Synthimed Labs

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

Holds 2 active US DMFs for eltrombopag, filing since 2025. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

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

Holds one active US DMF for eltrombopag, filing since 2014. 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
04

Biocon

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

Holds one active US DMF for eltrombopag, 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
05

Granules India

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

Holds 2 active US DMFs for eltrombopag, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

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

Deva Holding

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

Holds one active US DMF for eltrombopag, filing since 2026. Its GMP is recognised in 12 markets.

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

Zydus Lifesciences

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

Holds one active US DMF for eltrombopag, filing since 2020. 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
08

Shilpa Pharma Lifesciences

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

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

Raks Pharma

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

Holds one active US DMF for eltrombopag, filing since 2017. 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
10

Zhejiang Hengkang Pharmaceutical

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

Holds one active US DMF for eltrombopag, filing since 2024. 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
11

Biophore India Pharmaceuticals

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

Holds one active US DMF for eltrombopag, filing since 2023. 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
12

Apitoria Pharma

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

Holds one active US DMF for eltrombopag, filing since 2021. 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
13

Changzhou Pharmaceutical Factory

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

Holds 3 active US DMFs for eltrombopag, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Cambrex Profarmaco Milano

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

Holds 2 active US DMFs for eltrombopag, filing since 2024. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15
Credentials confirmed against the regulator files on 25 July 2026

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

US DMF
1 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
16
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eltrombopag, filing since 2024. 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
17

Quimica Sintetica

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

Holds one active US DMF for eltrombopag, filing since 2023. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Extrovis EU

Switzerland
Makes the API

Holds one active US DMF for eltrombopag, filing since 2023. Its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
19

Optimus Drugs

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Guangdong Raffles Pharmatech

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

Holds one active US DMF for eltrombopag, filing since 2023.

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

19 more manufacturers hold filings for eltrombopag

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

BioconGranules IndiaDeva HoldingZydus LifesciencesShilpa Pharma LifesciencesRaks PharmaZhejiang Hengkang PharmaceuticalBiophore India PharmaceuticalsApitoria PharmaChangzhou Pharmaceutical FactoryCambrex Profarmaco MilanoShanghai Desano Chemical PharmaceuticalChunghwa Chemical Synthesis & BiotechQuimica SinteticaExtrovis EUOptimus DrugsGuangdong Raffles Pharmatech
Open the full list with a free account

Contract manufacturers (2)

Zhejiang Langhua Pharmaceutical China Alfred E. Tiefenbacher (GmbH Germany

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

Finished-dose makers (39)

Teva Israel Zentiva, k.s Czech Republic Apotex Canada Dr. Reddy's Laboratories India Glenmark Pharmaceuticals s.r.o Czech Republic Olpha Latvia Viatris United States Gsk Vaccines United Kingdom Tuteur S A C I F I A Argentina Cipla India Natco Pharma India Novartis Switzerland Pharmascience Canada Sandoz Switzerland Siegfried Spain Synthon Hispania, S.L Spain STADA Arzneimittel Germany Glaxo Operations Uk United Kingdom Glaxo Wellcome S/A Spain Novartis Farmacéutica, S. A Spain

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.

Map eltrombopag 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 4 yrs Shortages 8 Finished dose 39 Contract mfrs 2

By country

India 19 China 8

Export price by year

Year Median Exporters
2025 $5987.58 15
2024 $6835.79 9
2023 $7905.57 12
2022 $10000.00 9

US dollars per kilogram, customs export unit values.