01 1Aurobindo Pharma Limited
02 1Ningbo Menovo Pharmaceutical Co. , Ltd.
03 1Oril Industry
04 2Permakem Asia Co., Ltd.
01 1Bae Lind erbumine
02 4Perindopril erbumine
01 1China
02 1France
03 1India
04 2Japan
Registration Number : 227MF10018
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2015-01-05
Latest Date of Registration : 2015-01-05
Registration Number : 227MF10137
Registrant's Address : 12B/F, Building 1, Ningbo R&D Park, No 999, YangFan Rd. , Hi-Tech district, Ningbo 31...
Initial Date of Registration : 2015-05-14
Latest Date of Registration : 2017-05-19
Registration Number : 228MF10112
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2016-06-10
Latest Date of Registration : 2016-06-10
Registration Number : 217MF11143
Registrant's Address : 7-6, Nihonbashi Odenmacho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2007-03-05
Registration Number : 217MF10333
Registrant's Address : 13, rue Auguste Desgene (') tais, 76210 Bolbec, FRANCE
Initial Date of Registration : 2005-08-09
Latest Date of Registration : 2008-11-21
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A AKOS015841351 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AKOS015841351, including repackagers and relabelers. The FDA regulates AKOS015841351 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AKOS015841351 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 AKOS015841351 supplier is an individual or a company that provides AKOS015841351 active pharmaceutical ingredient (API) or AKOS015841351 finished formulations upon request. The AKOS015841351 suppliers may include AKOS015841351 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 AKOS015841351 Drug Master File in Japan (AKOS015841351 JDMF) empowers AKOS015841351 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 AKOS015841351 JDMF during the approval evaluation for pharmaceutical products. At the time of AKOS015841351 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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