Molecules / Gefitinib / India

Gefitinib API manufacturers in India

CAS 184475-35-2 ATC L01XE02 Updated 9 July 2026
11
India-based manufacturers with an active filing of 17 worldwide
$1799.46
median export price per kg, all origins $941.31 to $2019.68 · 11 exporters · 2025
Showing 7 of 11 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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

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
05

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
06

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
07

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

4 more manufacturers in India hold filings for gefitinib

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

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How this list is built

This page filters the worldwide Gefitinib manufacturer list to companies based in India. 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. Read the full method.

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