Molecules / Medroxyprogesterone

Medroxyprogesterone API manufacturers

CAS 71-58-9 Updated 9 July 2026
16
manufacturers with an active filing 16 of them hold a US DMF or a CEP
$5689.59
median export price per kg $4812.91 to $5947.26 · 7 exporters · 2025
37
shortage records on file across 4 countries
384
finished-dose makers across 50 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bayer S/A

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

Holds one active US DMF for medroxyprogesterone, filing since 1984. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
46 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Mankind Pharma

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

Registered with SFDA (Saudi Arabia) for medroxyprogesterone. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
How this listing is sourced EDQM certificate database
View profile
03

Bayer

Germany
Makes the API

Holds one valid CEP for medroxyprogesterone, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
22 markets
How this listing is sourced EDQM certificate database
View profile
04

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 medroxyprogesterone, filing since 2014. 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
05

Amphastar Nanjing Pharmaceuticals

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

Holds one active US DMF for medroxyprogesterone, filing since 2018. 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
06

Yangzhou Aurisco Pharmaceutical

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

Registered with SFDA (Saudi Arabia) for medroxyprogesterone. 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 FDA, List of Drug Master Files
View profile
07

Sterling

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

Holds one valid CEP for medroxyprogesterone, filing since 2012. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
08

Aresko Life Sciences

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

Registered with SFDA (Saudi Arabia) for medroxyprogesterone. 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 FDA, List of Drug Master Files
View profile
09

Abbott Healthcare Products

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

Its GMP is recognised in 4 markets.

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

Farmabios

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

Holds one active US DMF for medroxyprogesterone, filing since 1997. 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
12

Taizhou Taifa Pharmaceuticals

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

Holds one active US DMF for medroxyprogesterone, filing since 2014.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

zhejiang xianju pharmaceutical

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

Holds one active US DMF for medroxyprogesterone, filing since 2006.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Hubei Gedian humanwell Pharmaceutical

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

Holds one active US DMF for medroxyprogesterone, filing since 2014. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

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

13 more manufacturers hold filings for medroxyprogesterone

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

Curia Spain S.A.UAmphastar Nanjing PharmaceuticalsYangzhou Aurisco PharmaceuticalSterlingAresko Life SciencesAbbott Healthcare ProductsFarmabiosJiangsu Grand Xianle PharmaceuticalTaizhou Taifa PharmaceuticalsXian Guokang Ruijin PharmaceuticalZhejiang Xianju Yangguang Bioproductszhejiang xianju pharmaceuticalHubei Gedian humanwell Pharmaceutical
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Contract manufacturers (5)

Hubei Gedian humanwell Pharmaceutical China Shree Venkatesh International India Jiangsu Jiaerke Pharmaceuticals Group China Montage Laboratories India Axplora Germany

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

Finished-dose makers (52)

Pfizer Brasil Ltda Brazil Viatris United States Amneal United States HIKMA ITALIA Italy Amphastar Nanjing United States Pfizer United States Senador Laboratories India Fresenius Kabi Ab Sweden Hospira United States Teva Israel Pfizer Manufacturing Belgium Belgium Orion Finland Abbott Biologicals Netherlands Pfizer Italia Italy Duopharma M Sdn Bhd Malaysia Incepta Pharmaceuticals Bangladesh Amneal Pharmaceuticals NY United States Cipla India Cyndea Pharma, S.L Spain Eurofarma Laboratorios Brazil

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.

Who makes medroxyprogesterone?

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

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Also on this molecule

Price history 2 yrs Shortages 37 Recalls 17 Finished dose 52 Contract mfrs 5

By country

China 8

Sold in these combinations

Estradiol + Medroxyprogesterone Acetate 2 APIs

Fixed-dose combinations containing medroxyprogesterone. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $5689.59 7
2024 $7667.61 6

US dollars per kilogram, customs export unit values.