Molecules / Gefitinib

Gefitinib API manufacturers

CAS 184475-35-2 ATC L01XE02 Updated 9 July 2026
17
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$1799.46
median export price per kg $941.31 to $2019.68 · 11 exporters · 2025
13
shortage records on file across 6 countries
246
finished-dose makers across 44 regulators
Showing 17 of 17 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 gefitinib, filing since 2017. 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
03

Alembic Pharmaceuticals

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

Holds one active US DMF and 2 valid CEPs for gefitinib, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
04

Synthon

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

Holds one active US DMF and one valid CEP for gefitinib, filing since 2015. Its GMP is recognised in 14 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
14 markets
05

Cipla

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

Holds one active US DMF and 4 valid CEPs for gefitinib, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
06

Natco Pharma

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

Holds 2 active US DMFs and one valid CEP for gefitinib, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
08

Sichuan Xieli Pharmaceutical

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

Holds one active US DMF for gefitinib, filing since 2012. 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
09

Sakar Healthcare

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

Holds one valid CEP for gefitinib, filing since 2026. Its GMP is recognised in 9 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
9 markets
How this listing is sourced EDQM certificate database
View profile
10

Wisdom Pharmaceutical

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

Holds one active US DMF for gefitinib, filing since 2025. 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
11

Yabao Pharmaceutical Group

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

Holds one active US DMF for gefitinib, filing since 2014. 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
12

zhejiang jiuzhou pharmaceutical

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

Holds one active US DMF for gefitinib, filing since 2016. 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
13

ScinoPharm Taiwan

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

Holds one active US DMF for gefitinib, filing since 2017. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
14

Ajinomoto

Belgium
Makes the API

Registered with SFDA (Saudi Arabia) for gefitinib. Its GMP is recognised in 23 markets.

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

Cdymax (India) Pharma

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

Holds one active US DMF for gefitinib, filing since 2024. 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
16

Zhejiang Huahai Pharmaceutical

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

Holds one valid CEP for gefitinib, filing since 2022. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
17

Công ty TNHH BRV Healthcare

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for gefitinib. 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

Contract manufacturers (5)

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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Export price by year

Year Median Exporters
2025 $1799.46 11
2023 $1650.00 10
2022 $1992.91 7

US dollars per kilogram, customs export unit values.