01 1Alembic Pharmaceuticals Limited
02 1ZHEJIANG GUOBANG PHARMACEUTICAL CO. , LTD.
01 2Azithromycin Dihydrate
01 1China
02 1India
Registration Number : 306MF10146
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2024-11-20
Latest Date of Registration : 2024-11-20
Registration Number : 308MF10026
Registrant's Address : No. 6, Weiwu Road, Hangzhou Gulf Shangyu Economic and Technological Development Zone,...
Initial Date of Registration : 2026-02-06
Latest Date of Registration : 2026-02-06
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PharmaCompass offers a list of Azithromycin Dihydrate 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 Azithromycin Dihydrate manufacturer or Azithromycin Dihydrate supplier for your needs.
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PharmaCompass also assists you with knowing the Azithromycin Dihydrate API Price utilized in the formulation of products. Azithromycin Dihydrate API Price is not always fixed or binding as the Azithromycin Dihydrate Price is obtained through a variety of data sources. The Azithromycin Dihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Azitrona Klonal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azitrona Klonal, including repackagers and relabelers. The FDA regulates Azitrona Klonal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azitrona Klonal 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 Azitrona Klonal supplier is an individual or a company that provides Azitrona Klonal active pharmaceutical ingredient (API) or Azitrona Klonal finished formulations upon request. The Azitrona Klonal suppliers may include Azitrona Klonal 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 Azitrona Klonal Drug Master File in Japan (Azitrona Klonal JDMF) empowers Azitrona Klonal 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 Azitrona Klonal JDMF during the approval evaluation for pharmaceutical products. At the time of Azitrona Klonal 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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