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
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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, Price,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.
PharmaCompass also assists you with knowing the Roxithromycin API Price utilized in the formulation of products. Roxithromycin API Price is not always fixed or binding as the Roxithromycin Price is obtained through a variety of data sources. The Roxithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rotramin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rotramin, including repackagers and relabelers. The FDA regulates Rotramin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rotramin 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 Rotramin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rotramin supplier is an individual or a company that provides Rotramin active pharmaceutical ingredient (API) or Rotramin finished formulations upon request. The Rotramin suppliers may include Rotramin API manufacturers, exporters, distributors and traders.
click here to find a list of Rotramin 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 Rotramin Drug Master File in Japan (Rotramin JDMF) empowers Rotramin 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 Rotramin JDMF during the approval evaluation for pharmaceutical products. At the time of Rotramin 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 Rotramin suppliers with JDMF on PharmaCompass.
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