Molecules / Letrozole

Letrozole API manufacturers

CAS 112809-51-5 ATC L02BG04 Updated 9 July 2026
14
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$4985.00
median export price per kg $1909.25 to $7938.10 · 25 exporters · 2025
46
shortage records on file across 4 countries
745
finished-dose makers across 51 regulators
Showing 14 of 14 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 letrozole, filing since 2011. 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
02

Synthimed Labs

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

Holds 2 active US DMFs and one valid CEP for letrozole, filing since 2008. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
03

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 letrozole, filing since 2008. 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
04

Natco Pharma

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

Holds 4 active US DMFs and one valid CEP for letrozole, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
05

Dr. Reddy's Laboratories

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

Holds one active US DMF for letrozole, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Synthon

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

Holds one valid CEP for letrozole, filing since 2024. Its GMP is recognised in 14 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced EDQM certificate database
View profile
09

Zydus Lifesciences

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

Holds one active US DMF for letrozole, filing since 2024. 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
10

ScinoPharm Taiwan

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

Holds one active US DMF for letrozole, filing since 2006. 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
11

Novartis

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

Holds one valid CEP for letrozole, filing since 2026. Its GMP is recognised in 15 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
15 markets
How this listing is sourced EDQM certificate database
View profile
13

Ind-Swift Laboratories

India
Makes the API

Registered with SFDA (Saudi Arabia) for letrozole. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Mac Chem Products India

India
Makes the API

Registered with SFDA (Saudi Arabia) for letrozole. 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

11 more manufacturers hold filings for letrozole

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

Open the full list with a free account

Contract manufacturers (4)

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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By country

Export price by year

Year Median Exporters
2025 $4985.00 25
2024 $5000.00 20
2023 $6669.91 19
2022 $6702.61 13

US dollars per kilogram, customs export unit values.