01 1GEDEON RICHTER Plc.
02 2INDUSTRIALE CHIMICA s. r. l.
03 1Newchem S. p. A.
04 1Sicor Societa (') Italiana Corticosteroidi S. r. l.
01 4Drospirenone
02 1Drospirenone
01 1Hungary
02 4Italy
Registration Number : 305MF10112
Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY
Initial Date of Registration : 2023-09-26
Latest Date of Registration : 2023-09-26
Registration Number : 303MF10024
Registrant's Address : Via E. H. Grieg, 13,21047 Saronno (VARESE) ITALY
Initial Date of Registration : 2021-02-01
Latest Date of Registration : 2021-02-01
Registration Number : 306MF10029
Registrant's Address : Via E. H. Grieg, 13, 21047 Saronno (Varese) ITALY
Initial Date of Registration : 2024-02-21
Latest Date of Registration : 2024-02-21
Registration Number : 306MF10044
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2024-03-21
Latest Date of Registration : 2024-03-21
Registration Number : 305MF10096
Registrant's Address : Piazzale Luigi Cadorna, 4-20123 MILANO, Italy
Initial Date of Registration : 2023-08-09
Latest Date of Registration : 2023-08-09
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.
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 Drospirenone Drug Master File in Japan (Drospirenone JDMF) empowers Drospirenone 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 Drospirenone JDMF during the approval evaluation for pharmaceutical products. At the time of Drospirenone 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 Drospirenone suppliers with JDMF on PharmaCompass.
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