01 1Bayer AG@[Undifferentiated Process Manufacturer] Bayer AG
02 2INDUSTRIAL CHIMICA SRL
03 1Industriale Chimica srl@LAB-SERVICE SAS
04 1NEWCHEM SpA@Microchem SRL
05 1Sicor Società Italiana Corticosteroidi Srl
01 1Aging Life Science Co., Ltd.
02 1Alvogen Korea Co., Ltd.
03 1Bayer Korea Ltd.
04 1Hyundai Pharmaceutical Co., Ltd.
05 1Samoh Pharmaceutical Co., Ltd.
06 1Sungjin Exim Co., Ltd.
01 6drospirenone
01 1Germany
02 5Italy
Registrant Name : Bayer Korea Ltd.
Registration Date : 2006-03-02
Registration Number : 309-2-ND
Manufacturer Name : Bayer AG@[Undifferentiated P...
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Max-Dohrn-Straße 8 10589 Berlin, ...
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2016-12-02
Registration Number : Su2395-2-ND
Manufacturer Name : INDUSTRIAL CHIMICA SRL
Manufacturer Address : Via EH Grieg, 13 - 21047 SARONNO (VA), Italy
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2018-03-12
Registration Number : No. 2395-2-ND(1)
Manufacturer Name : INDUSTRIAL CHIMICA SRL
Manufacturer Address : Via EH Grieg, 13 - 21047 SARONNO (VA), Italy
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 434-44-ND
Manufacturer Name : Industriale Chimica srl@LAB-...
Manufacturer Address : Via EH Grieg 13 21047 Saronno (Varese), Italy @455 Zone Artisanale du Verdier LA ROCH...
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-03-12
Registration Number : Number 133-13-ND
Manufacturer Name : NEWCHEM SpA@Microchem SRL
Manufacturer Address : Via Roveggia, 47, 37136 VERONA (VR), Italy@Via Turati, 2, 29017 Fiorenzuola d'Arda (P...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-01-04
Registration Number : 711-13-ND
Manufacturer Name : Sicor Società Italiana Cort...
Manufacturer Address : 13048, Tenuta S. Alessandro, Santhia (VC), Italy
A Drospirenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Drospirenone, including repackagers and relabelers. The FDA regulates Drospirenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Drospirenone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Drospirenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Drospirenone supplier is an individual or a company that provides Drospirenone active pharmaceutical ingredient (API) or Drospirenone finished formulations upon request. The Drospirenone suppliers may include Drospirenone API manufacturers, exporters, distributors and traders.
click here to find a list of Drospirenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Drospirenone Drug Master File in Korea (Drospirenone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Drospirenone. The MFDS reviews the Drospirenone KDMF as part of the drug registration process and uses the information provided in the Drospirenone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Drospirenone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Drospirenone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Drospirenone suppliers with KDMF on PharmaCompass.
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