Molecules / Prasterone

Prasterone API manufacturers

CAS 53-43-0 Updated 9 July 2026
7
manufacturers with an active filing 7 of them hold a US DMF or a CEP
28
finished-dose makers across 21 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Pfizer

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

Holds one active US DMF for prasterone, filing since 2014. Its 2019 FDA inspection closed as NAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
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02
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for prasterone, filing since 2014. 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
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03
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for prasterone, filing since 2013. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Symbiotec Pharmalab

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

Its 2022 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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05
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs for prasterone, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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4 more manufacturers hold filings for prasterone

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

Symbiotec PharmalabJiangsu Jiaerke Pharmaceuticals GroupHubei Goto BiopharmHubei Goto Biotechnology
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Contract manufacturers (1)

Hubei Gedian humanwell Pharmaceutical China

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

Finished-dose makers (4)

Inmenol Industrial Laboratorios Dominican Republic Mundipharma Germany Cosette Pharmaceuticals United States Laboratorios Casasco S A I C Argentina

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 prasterone?

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

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Also on this molecule

Recalls 1 Finished dose 4 Contract mfrs 1