Levonorgestrel

Overview

Levonorgestrel is a synthetic progestogen used in various hormonal contraceptives, including emergency contraceptive pills. It works by preventing ovulation and fertilization of an egg.

API suppliers (15)

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

• ZHEJIANG XIANJU PHARMACEUTICAL CO LTD1 active DMF
• Hunan KYF Pharmaceutical. Co., LtdChina1 active DMF
• VALARY LAB PRIVATE LIMITEDIndia1 active DMF GMP on record
• Bayer PlcUnited Kingdom1 active DMF
• INDUSTRIALE CHIMICA SRLItaly1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• Cipla USA, Inc.USA1 active DMF
• Formosa Laboratories, Inc.Taiwan1 active DMF GMP on record
• Lupin LimitedIndia1 active DMF GMP on record
• SYMBIOTEC PHARMALAB LIMITED1 active DMF GMP on record
• STERLING CHEMICAL MALTA LTDMalta1 active DMF GMP on record
• Hubei Gedian Humanwell Pharmaceutical Co. LtdChina1 active DMF GMP on record
• INDO PHYTO CHEMICALS PRIVATE LTD
• YANGZHOU PHARMACEUTICAL FACTORY
• HOECHST MARION ROUSSEL SA

EU CEP holders (2)

Companies holding a valid EU Certificate of Suitability (CEP) for Levonorgestrel, 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 (18 approved US products), the latest listed US patent on Levonorgestrel expires 7 Sept 2040 and exclusivity 29 Jun 2026. Generic API sourcing typically opens up once these lapse.

Therapeutic areas