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.
Country recorded for 9 of 11 suppliers.
8 of 11 hold a GMP certificate on record in the EU or UK registers · 1 holds a European CEP for this substance
- NEWCHEM SPAItaly2 active DMF GMP on record
- INDUSTRIALE CHIMICA SRLItaly1 active DMF GMP on record
- STERLING SPAItaly1 active DMF GMP on record
- Bayer AGGermany1 active DMF
- Gedeon Richter Usa1 active DMF
- TAPI NL BVNetherlands1 active DMF
- Lupin LimitedIndia1 active DMF GMP on record
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- Hubei Gedian Humanwell Pharmaceutical Co. LtdChina1 active DMF GMP on record
- SYMBIOTEC PHARMALAB LTD1 active DMF GMP on record
- Gedeon RichterHungaryCEP GMP on record
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
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