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
10
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A NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE, including repackagers and relabelers. The FDA regulates NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE 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 & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE supplier is an individual or a company that provides NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE active pharmaceutical ingredient (API) or NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE finished formulations upon request. The NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE suppliers may include NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE 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 & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE Drug Master File in Japan (NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE JDMF) empowers NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE 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 & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE JDMF during the approval evaluation for pharmaceutical products. At the time of NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE 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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