01 1Smilax Laboratories Ltd.
01 1Cloperastine Hydrochloride
01 1India
Registration Number : 305MF10046
Registrant's Address : Plot No. 12/A, Phase III, IDA, Jeedimetla, Hyderabad-500 055, Telangana State, India
Initial Date of Registration : 2023-04-05
Latest Date of Registration : 2024-07-17
A Cloperastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cloperastine, including repackagers and relabelers. The FDA regulates Cloperastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cloperastine 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 Cloperastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cloperastine supplier is an individual or a company that provides Cloperastine active pharmaceutical ingredient (API) or Cloperastine finished formulations upon request. The Cloperastine suppliers may include Cloperastine API manufacturers, exporters, distributors and traders.
click here to find a list of Cloperastine 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 Cloperastine Drug Master File in Japan (Cloperastine JDMF) empowers Cloperastine 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 Cloperastine JDMF during the approval evaluation for pharmaceutical products. At the time of Cloperastine 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 Cloperastine suppliers with JDMF on PharmaCompass.
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