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 BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE supplier is an individual or a company that provides BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE active pharmaceutical ingredient (API) or BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE finished formulations upon request. The BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE suppliers may include BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE 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 BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE Drug Master File in Japan (BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE JDMF) empowers BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE 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 BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE JDMF during the approval evaluation for pharmaceutical products. At the time of BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE 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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