01 1Permakem Asia Co., Ltd.
02 1UBE Inc.
01 1Japanese Pharmacopoeia nitrendipine (production only)
02 1Nitrendipine
01 2Japan
Japanese Pharmacopoeia Nitrendipine (for manufacturing only)
Registration Number : 219MF10330
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2007-11-05
Latest Date of Registration : 2007-11-05
Registration Number : 217MF10717
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2007-10-24
A Nitrendipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrendipine, including repackagers and relabelers. The FDA regulates Nitrendipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrendipine 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 Nitrendipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrendipine supplier is an individual or a company that provides Nitrendipine active pharmaceutical ingredient (API) or Nitrendipine finished formulations upon request. The Nitrendipine suppliers may include Nitrendipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrendipine 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 Nitrendipine Drug Master File in Japan (Nitrendipine JDMF) empowers Nitrendipine 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 Nitrendipine JDMF during the approval evaluation for pharmaceutical products. At the time of Nitrendipine 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 Nitrendipine suppliers with JDMF on PharmaCompass.
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