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 : 2025-04-16
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
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PharmaCompass offers a list of Roxithromycin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Roxithromycin manufacturer or Roxithromycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roxithromycin manufacturer or Roxithromycin supplier.
A Rulide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rulide, including repackagers and relabelers. The FDA regulates Rulide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rulide 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 Rulide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rulide supplier is an individual or a company that provides Rulide active pharmaceutical ingredient (API) or Rulide finished formulations upon request. The Rulide suppliers may include Rulide API manufacturers, exporters, distributors and traders.
click here to find a list of Rulide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Rulide Drug Master File in Japan (Rulide JDMF) empowers Rulide 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 Rulide JDMF during the approval evaluation for pharmaceutical products. At the time of Rulide 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 Rulide suppliers with JDMF on PharmaCompass.
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