Dronedarone Hydrochloride
Overview
Dronedarone Hydrochloride is an antiarrhythmic medication used to treat certain types of irregular heartbeat, such as atrial fibrillation or atrial flutter. It works by helping to restore normal heart rhythm and maintain a regular, steady heartbeat.
API suppliers (12)
Suppliers of Dronedarone Hydrochloride 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 12 suppliers.
7 of 12 hold a GMP certificate on record in the EU or UK registers
- Wisdom Pharmaceutical Co., LtdChina2 active DMF
- Alkem Laboratories LimitedIndia1 active DMF GMP on record
- Piramal Pharma LimitedIndia1 active DMF GMP on record
- Sanofi Winthrop IndustrieFrance1 active DMF GMP on record
- UNIMARK REMEDIES LTDIndia1 active DMF
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
- ALP PHARM BEIJING CO LTD1 active DMF
- Viyash Scientific LtdIndia1 active DMF GMP on record
- Apotex Pharmachem India Pvt. Ltd.India
- SINOPEP JIANGSU INC
- MYLAN LABORATORIES LTD GMP on record
EU CEP holders (4)
Companies holding a valid EU Certificate of Suitability (CEP) for Dronedarone Hydrochloride, 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.
Therapeutic areas
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