01 1Alembic Pharmaceuticals Limited
02 1Huangshi Shixing Pharmaceutical Co. , Ltd.
01 1ROXITHROMYCIN
02 1Roxithromycin
01 1China
02 1India
Registration Number : 218MF10414
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2006-04-14
Latest Date of Registration : 2019-06-25
Registration Number : 302MF10125
Registrant's Address : No. 73 East Jinshan Road, Huangjinshan Development Zone, Huangshi, Hubei, China
Initial Date of Registration : 2020-10-08
Latest Date of Registration : 2023-10-04
A Roxithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxithromycin, including repackagers and relabelers. The FDA regulates Roxithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxithromycin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Roxithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roxithromycin supplier is an individual or a company that provides Roxithromycin active pharmaceutical ingredient (API) or Roxithromycin finished formulations upon request. The Roxithromycin suppliers may include Roxithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Roxithromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Roxithromycin Drug Master File in Japan (Roxithromycin JDMF) empowers Roxithromycin 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 Roxithromycin JDMF during the approval evaluation for pharmaceutical products. At the time of Roxithromycin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Roxithromycin suppliers with JDMF on PharmaCompass.
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