01 1Aurobindo Pharma Limited
02 1Cambrex Profarmaco Milano S. r. l.
03 1ERREGIERRE S. p. A.
04 1HANMI FINE CHEMICAL CO. , LTD.
05 1Kyongbo Pharmaceutical Co. , Ltd.
06 1Olon S. p. A.
01 2Raloxifene Hydrochloride
02 2Raloxifene hydrochloride
03 2Raloxifene hydrochloride hydrate
01 1India
02 2Italy
03 2South Korea
04 1U.S.A
Registration Number : 228MF10113
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2016-06-17
Latest Date of Registration : 2016-06-17
Registration Number : 227MF10039
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2015-02-09
Latest Date of Registration : 2015-02-09
Registration Number : 226MF10007
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2014-01-08
Latest Date of Registration : 2014-11-17
Raloxifene hydrochloride hydrate
Registration Number : 227MF10053
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2015-02-18
Latest Date of Registration : 2015-02-18
Raloxifene hydrochloride hydrate
Registration Number : 227MF10048
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2015-02-09
Latest Date of Registration : 2023-09-20
Registration Number : 303MF10064
Registrant's Address : Strada Rivoltana Km. 6/7 20053 Rodano (MI), Italy
Initial Date of Registration : 2021-04-13
Latest Date of Registration : 2021-04-13
A Raloxifene Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Raloxifene Hydrochloride, including repackagers and relabelers. The FDA regulates Raloxifene Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Raloxifene Hydrochloride 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 Raloxifene Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Raloxifene Hydrochloride supplier is an individual or a company that provides Raloxifene Hydrochloride active pharmaceutical ingredient (API) or Raloxifene Hydrochloride finished formulations upon request. The Raloxifene Hydrochloride suppliers may include Raloxifene Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Raloxifene Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Raloxifene Hydrochloride Drug Master File in Japan (Raloxifene Hydrochloride JDMF) empowers Raloxifene Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Raloxifene Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Raloxifene Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Raloxifene Hydrochloride suppliers with JDMF on PharmaCompass.
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