Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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01 1CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
02 1DAEWOONG BIO INC.
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01 1Cloxacillin sodium hydrate
02 1[Japanese Pharmacopoeia] cloxacillin sodium
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01 1Netherlands
02 1South Korea
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Registration Number : 227MF10133
Registrant's Address : Bhai Mohan Singh Nagar, Toansa, District SBS Nagar (Nawanshahr), Punjab-144 533, Indi...
Initial Date of Registration : 2015-04-30
Latest Date of Registration : 2015-04-30
[Japanese Pharmacopoeia] Cloxacillin Sodium
Registration Number : 218MF11024
Registrant's Address : 12 BONGEUNSA-RO, 114-GIL, GANGNAM-GU, SEOUL, 135-715 KOREA
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2006-12-28
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A Cloxapen;Cloxacap;Orbenin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cloxapen;Cloxacap;Orbenin, including repackagers and relabelers. The FDA regulates Cloxapen;Cloxacap;Orbenin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cloxapen;Cloxacap;Orbenin 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 Cloxapen;Cloxacap;Orbenin supplier is an individual or a company that provides Cloxapen;Cloxacap;Orbenin active pharmaceutical ingredient (API) or Cloxapen;Cloxacap;Orbenin finished formulations upon request. The Cloxapen;Cloxacap;Orbenin suppliers may include Cloxapen;Cloxacap;Orbenin 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 Cloxapen;Cloxacap;Orbenin Drug Master File in Japan (Cloxapen;Cloxacap;Orbenin JDMF) empowers Cloxapen;Cloxacap;Orbenin 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 Cloxapen;Cloxacap;Orbenin JDMF during the approval evaluation for pharmaceutical products. At the time of Cloxapen;Cloxacap;Orbenin 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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