01 1Biocon Limited
02 1Boehringer Ingelheim Pharma GmbH & Co. K.G.
03 1Zhejiang Hisoar Chuannan Pharmaceutical Co. , Ltd.
01 3Repaglinide
01 1China
02 1Germany
03 1India
Registration Number : 231MF10044
Registrant's Address : 20th KM, Hosur Road, Electronics City-560100, Bengaluru, India
Initial Date of Registration : 2019-02-13
Latest Date of Registration : 2019-02-13
Registration Number : 221MF10144
Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2017-05-16
Registration Number : 306MF10117
Registrant's Address : No. 23,5th Donghai Avenue Zhejiang Chemical materials base Linhai zone, Linhai City, ...
Initial Date of Registration : 2024-08-28
Latest Date of Registration : 2024-08-28
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A data (1) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of data (1), including repackagers and relabelers. The FDA regulates data (1) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. data (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.
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A data (1) supplier is an individual or a company that provides data (1) active pharmaceutical ingredient (API) or data (1) finished formulations upon request. The data (1) suppliers may include data (1) API manufacturers, exporters, distributors and traders.
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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 data (1) Drug Master File in Japan (data (1) JDMF) empowers data (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 data (1) JDMF during the approval evaluation for pharmaceutical products. At the time of data (1) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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