Molecules / Raloxifene

Raloxifene API manufacturers

CAS 84449-90-1 ATC G03XC01 Updated 9 July 2026
15
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$890.00
median export price per kg $526.50 to $920.00 · 5 exporters · 2024
28
shortage records on file across 4 countries
143
finished-dose makers across 29 regulators
Showing 15 of 15 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for raloxifene, filing since 2002. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
02

Cadila Pharmaceuticals

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

Holds one active US DMF for raloxifene, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Erregierre

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

Holds one active US DMF and one valid CEP for raloxifene, filing since 2002. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Olon

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

Holds one active US DMF and one valid CEP for raloxifene, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Apotex

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

Holds one valid CEP for raloxifene, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced EDQM certificate database
View profile
07

Hetero

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

Holds 2 active US DMFs for raloxifene, filing since 2011. 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
08

Alivus Life Sciences

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

Holds 2 active US DMFs for raloxifene, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 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
10

Raks Pharma

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

Holds one active US DMF for raloxifene, 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
11

Apitoria Pharma

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

Holds one active US DMF and 2 valid CEPs for raloxifene, filing since 2012. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Cambrex Profarmaco Milano

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

Holds 2 active US DMFs for raloxifene, filing since 2009. 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
13

Glochem Industries

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

Holds 2 active US DMFs for raloxifene, filing since 2008. Its 2024 FDA inspection closed as VAI.

US DMF
2 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
14

Laxai Life Sciences

India
Makes the API

Registered with SFDA (Saudi Arabia) for raloxifene. Its 2025 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

Công ty cổ phần Korea United Pharm. Int' L

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for raloxifene. 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

12 more manufacturers hold filings for raloxifene

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 (1)

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
Price band
Customs export unit values for 2024. 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
2024 $890.00 5
2023 $881.19 9
2022 $937.92 11

US dollars per kilogram, customs export unit values.