Ciprofloxacin Hydrochloride is an active pharmaceutical ingredient (API) with the molecular formula C17H19ClFN3O3. It is the anhydrous form of the monohydrochloride salt of Ciprofloxacin which belongs to a class of drugs called quinolone antibiotics. It has an anti-bacterial property that works by stopping the growth of bacteria. The medicines prepared from this API are used to treat various bacterial illnesses such as Urogenital Infections, Respiratory Tract Infections, Gastrointestinal Infections, Typhoid, Bone and Joint Infections, Skin and Soft Tissue Infections, Sepsis, and Other Systemic Infections. Also, the finished product containing Ciprofloxacin HCL functions as a Topoisomerase II Inhibitors and Cytochrome P-450 CYP1A2 Inhibitors. Key players in manufacturing Ciprofloxacin HCl include Dr. Reddy's Labs, Bayer AG, Aurobindo Pharma, Shangyu Jingxin Pharmaceutical Co. Ltd., Zhejiang Longhua Pharmaceutical Co. Ltd., and Zhejiang Guobang Pharmaceutical Co., Ltd.
Product Specific Details
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CAS No.
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93107-08-5
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HS Code
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29419030
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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
