Drospirenone

Overview

Drospirenone is a synthetic progestin used in oral contraceptive pills. It is characterized by its ability to mimic the natural hormone progesterone and also possesses anti-androgenic and slight anti-mineralocorticoid properties.

API suppliers (11)

Suppliers of Drospirenone evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• NEWCHEM SPAItaly2 active DMF GMP on record
• Bayer PlcUnited Kingdom1 active DMF
• Gedeon Richter Usa1 active DMF
• INDUSTRIALE CHIMICA SRLItaly1 active DMF GMP on record
• STERLING SPAItaly1 active DMF GMP on record
• Lupin LimitedIndia1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• SYMBIOTEC PHARMALAB LTD1 active DMF GMP on record
• Hubei Gedian Humanwell Pharmaceutical Co. LtdChina1 active DMF GMP on record
• Gedeon RichterHungaryCEP GMP on record

EU CEP holders (5)

Companies holding a valid EU Certificate of Suitability (CEP) for Drospirenone, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Drospirenone expires 28 Jun 2031. Generic API sourcing typically opens up once these lapse.

Therapeutic areas