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