01 1Biovet JSC
02 1ERCROS S. A.
03 1HEC PHARM CO. ,LTD
04 2Ningxia Qiyuan Pharmaceutical Co. , Ltd.
01 1Erythromycin
02 1Erythromycin Chioshianeito
03 3erythromycin
01 1Bulgaria
02 3China
03 1Spain
Registration Number : 217MF10893
Registrant's Address : 39 Petar Rakov Street 4550 Peshtera, Bulgaria
Initial Date of Registration : 2005-11-07
Latest Date of Registration : 2010-03-09
Registration Number : 218MF10942
Registrant's Address : Paseo del Deleite, s/n 28300 Aranjuez, Madrid Spain
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
Registration Number : 231MF10067
Registrant's Address : No. 62 Binjiang Road, Yidu, Hubei Province, P. R. China
Initial Date of Registration : 2019-03-11
Latest Date of Registration : 2019-03-11
Registration Number : 227MF10101
Registrant's Address : No. 1 Qiyuan Street, Wangyuan Industrial Area, Yinchuan City, Ningxia 750101, P. R. C...
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2015-04-09
Registration Number : 228MF10123
Registrant's Address : No. 1 Qiyuan Street, Wangyuan Industrial Area, Yinchuan City, Ningxia 750101, P. R. C...
Initial Date of Registration : 2016-07-06
Latest Date of Registration : 2016-07-06
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A Erythromycin A 11,12-Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin A 11,12-Carbonate, including repackagers and relabelers. The FDA regulates Erythromycin A 11,12-Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin A 11,12-Carbonate 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 Erythromycin A 11,12-Carbonate supplier is an individual or a company that provides Erythromycin A 11,12-Carbonate active pharmaceutical ingredient (API) or Erythromycin A 11,12-Carbonate finished formulations upon request. The Erythromycin A 11,12-Carbonate suppliers may include Erythromycin A 11,12-Carbonate 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 Erythromycin A 11,12-Carbonate Drug Master File in Japan (Erythromycin A 11,12-Carbonate JDMF) empowers Erythromycin A 11,12-Carbonate 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 Erythromycin A 11,12-Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin A 11,12-Carbonate 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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