01 1Xellia (Taizhou) Pharmaceuticals Co. ,Ltd
02 1Xellia Pharmaceuticals AS
01 2Japanese Pharmacopoeia bacitracin
01 2Denmark
Japanese Pharmacopoeia Bacitracin
Registration Number : 218MF10935
Registrant's Address : Harbitzalle(´)en 3, P. O. Box 158 Skφyen N-0212 Oslo, Norway
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Japanese Pharmacopoeia Bacitracin
Registration Number : 225MF10193
Registrant's Address : 108 Binhai Road, Taizhou, Zhejiang 318000 PRC, China
Initial Date of Registration : 2013-10-09
Latest Date of Registration : 2013-10-09
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A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, including repackagers and relabelers. The FDA regulates NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC supplier is an individual or a company that provides NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC active pharmaceutical ingredient (API) or NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC finished formulations upon request. The NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC suppliers may include NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Drug Master File in Japan (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC JDMF) empowers NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC JDMF during the approval evaluation for pharmaceutical products. At the time of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 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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