Molecules / Exemestane

Exemestane API manufacturers

CAS 107868-30-4 ATC L02BG06 Updated 9 July 2026
12
manufacturers with an active filing 10 of them hold a US DMF or a CEP
22
shortage records on file across 3 countries
343
finished-dose makers across 46 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

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 exemestane, 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
03

Curia Spain S.A.U

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

Holds one active US DMF for exemestane, filing since 2004. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Sterling

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

Holds one active US DMF for exemestane, filing since 2009. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
3 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 exemestane, filing since 2023. 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

ScinoPharm Taiwan

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

Holds one active US DMF for exemestane, filing since 2007. 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
07

Synthon

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

Holds one valid CEP for exemestane, filing since 2025. 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
08

Coral Drugs

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

Holds 2 active US DMFs for exemestane, filing since 2023. Its 2019 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Farmabios

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

Holds one active US DMF for exemestane, filing since 2012. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Cedarburg Pharmaceuticals

United States
Makes the API

Registered with SFDA (Saudi Arabia) for exemestane.

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

Qilu Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for exemestane.

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

9 more manufacturers hold filings for exemestane

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

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Contract manufacturers (4)

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

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

Who makes exemestane?

Ask Fred which manufacturers are on record for exemestane and what filings they hold.

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