01 1Corden Pharma Bergamo S. p. A.
01 1METRONIDAZOLE
01 1Italy
Registration Number : 220MF10104
Registrant's Address : Via Bergamo, 121, I-24047, TREVIGLIO (Bg), Italy
Initial Date of Registration : 2008-04-11
Latest Date of Registration : 2015-11-12
A PYLERA-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PYLERA-1, including repackagers and relabelers. The FDA regulates PYLERA-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PYLERA-1 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 PYLERA-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PYLERA-1 supplier is an individual or a company that provides PYLERA-1 active pharmaceutical ingredient (API) or PYLERA-1 finished formulations upon request. The PYLERA-1 suppliers may include PYLERA-1 API manufacturers, exporters, distributors and traders.
click here to find a list of PYLERA-1 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 PYLERA-1 Drug Master File in Japan (PYLERA-1 JDMF) empowers PYLERA-1 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 PYLERA-1 JDMF during the approval evaluation for pharmaceutical products. At the time of PYLERA-1 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 PYLERA-1 suppliers with JDMF on PharmaCompass.
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