01 1Olon S. p. A.
02 1Vasudha Pharma Chem Limited
01 1Loperamide Hydrochloride
02 1Loperamide hydrochloride
01 1India
02 1Italy
Registration Number : 217MF10757
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2020-10-01
Registration Number : 304MF10091
Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad-500 038, Telangana State, India.
Initial Date of Registration : 2022-06-22
Latest Date of Registration : 2024-04-18
A Loperamide Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loperamide Hydrochloride, including repackagers and relabelers. The FDA regulates Loperamide Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loperamide 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 Loperamide Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loperamide Hydrochloride supplier is an individual or a company that provides Loperamide Hydrochloride active pharmaceutical ingredient (API) or Loperamide Hydrochloride finished formulations upon request. The Loperamide Hydrochloride suppliers may include Loperamide Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Loperamide 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 Loperamide Hydrochloride Drug Master File in Japan (Loperamide Hydrochloride JDMF) empowers Loperamide 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 Loperamide Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Loperamide 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 Loperamide Hydrochloride suppliers with JDMF on PharmaCompass.
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