Aspen API. More than just an API™
01 1Aspen Oss BV@Aspen Oss BV
02 1Bayer AG "Bergkamen" (All processes except pulverization) @ Bayer AG "Berlin-Charlottenburg" (Pulverization process)
03 1Bayer Pharma AG "Bergkamen" (all processes except the micronization process) @ Bayer Pharma AG "Berlin-Charlottenburg" (micronization process)
04 1Bayer Pharma AG Bergkamen Facility (All processes except micronization) @ Bayer Pharma AG Berlin-Charlottenburg Facility (Micronization process)
01 1Bayer Korea Co., Ltd.
02 1Hyundai Pharmaceutical Co., Ltd.
03 1J-Tech Biogen
04 1Synex Co., Ltd.
01 4Estradiol valerate
01 3Germany
02 1Netherlands
Aspen API. More than just an API™
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-05-26
Registration Number : 20220526-181-I-638-07
Manufacturer Name : Aspen Oss BV@Aspen Oss BV
Manufacturer Address : Kloosterstraat 6, Oss, 5349 AB, The Netherlands@Veersemeer 4, Oss, 5347 JN, The Nethe...
Registrant Name : J-Tech Biogen
Registration Date : 2013-05-15
Registration Number : 20121228-181-I-165-04(2)
Manufacturer Name : Bayer Pharma AG "Bergkamen" ...
Manufacturer Address : Ernst-Schering-Str. 14, D-59192@Max-Dohrn-Str. 8, D-10589 Berlin
Registrant Name : Bayer Korea Co., Ltd.
Registration Date : 2012-12-28
Registration Number : 20121228-181-I-165-04
Manufacturer Name : Bayer AG "Bergkamen" (All pr...
Manufacturer Address : Ernst-Schering-Straße 14, 59192 Bergkamen, Germany@Max-Dohrn-Straße 8, 10589 Berlin...
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2013-04-10
Registration Number : 20121228-181-I-165-04(1)
Manufacturer Name : Bayer Pharma AG Bergkamen Fa...
Manufacturer Address : Ernst-Schering-Strasse 14 59192 Bergkamen@Max-Dohrn-Strasse 8-10 10589 Berlin
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PharmaCompass offers a list of Estradiol Valerate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Estradiol Valerate manufacturer or Estradiol Valerate supplier for your needs.
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A Primogyna manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Primogyna, including repackagers and relabelers. The FDA regulates Primogyna manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Primogyna 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 Primogyna manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Primogyna supplier is an individual or a company that provides Primogyna active pharmaceutical ingredient (API) or Primogyna finished formulations upon request. The Primogyna suppliers may include Primogyna API manufacturers, exporters, distributors and traders.
click here to find a list of Primogyna suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Primogyna Drug Master File in Korea (Primogyna KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Primogyna. The MFDS reviews the Primogyna KDMF as part of the drug registration process and uses the information provided in the Primogyna KDMF to evaluate the safety and efficacy of the drug.
After submitting a Primogyna 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 Primogyna API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Primogyna suppliers with KDMF on PharmaCompass.
