Azithromycin is an active pharmaceutical ingredient having the molecular formula C38H72N2O12. It is present in white powder form. It is applied in various dosage forms of finished products, such as a tablet, injections, and ophthalmics. It has an antibiotic property used to treat several bacterial infections, including middle ear infections, strep throat, and pneumonia. It will resist harmful microorganisms from growing and may fight a large variety of microorganisms, together with several within the eubacteria family. It is also utilized for the preparation of COVID-19 drugs. It is an active ingredient in products such as Azithromycin Dihydrate, monohydrate, and trihydrate. The major global market players include Alembic Pharmaceutical Limited, Pfizer, Teva, Mylan, Hainan Poly Pharm, and Hainan Hailing Chemipharma Corporation.
Product Specific Details
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CAS No.
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83905-01-5
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HS Code
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29419090
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Grade
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USP, IP, Ph. Eur/EP
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Approved Facility
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CDSCO (FDA India), USFDA
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Certifications
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GMP, cGMP, CEP
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Approved Facility/Certification Definitions:
CDSCO- The Central Drugs Standard Control Organization (CDSCO) - Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
USFDA - The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. FDA is also responsible for advancing the public health by accelerating innovations to make medicines more effective and providing the public with accurate, science-based information on medicines and food to improve their health. FDA plays a significant role in addressing the Nation's counterterrorism capability and ensuring the security of the food supply.
GMP- Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
cGMP- It refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations.
CEP - The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph.
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Countries Covered:
• China
• India
• USA
• Germany
