01 1Flamma S. p. A.
01 1Methacholine Chloride
01 1Italy
Registration Number : 304MF10146
Registrant's Address : Via Bedeschi, 22 24040 Chignolo d'Isola (Bergamo) Italy
Initial Date of Registration : 2022-11-02
Latest Date of Registration : 2022-11-02
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A METHACHOLINE CHLORIDE [USP MONOGRAPH] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of METHACHOLINE CHLORIDE [USP MONOGRAPH], including repackagers and relabelers. The FDA regulates METHACHOLINE CHLORIDE [USP MONOGRAPH] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. METHACHOLINE CHLORIDE [USP MONOGRAPH] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A METHACHOLINE CHLORIDE [USP MONOGRAPH] supplier is an individual or a company that provides METHACHOLINE CHLORIDE [USP MONOGRAPH] active pharmaceutical ingredient (API) or METHACHOLINE CHLORIDE [USP MONOGRAPH] finished formulations upon request. The METHACHOLINE CHLORIDE [USP MONOGRAPH] suppliers may include METHACHOLINE CHLORIDE [USP MONOGRAPH] API manufacturers, exporters, distributors and traders.
click here to find a list of METHACHOLINE CHLORIDE [USP MONOGRAPH] suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 METHACHOLINE CHLORIDE [USP MONOGRAPH] Drug Master File in Japan (METHACHOLINE CHLORIDE [USP MONOGRAPH] JDMF) empowers METHACHOLINE CHLORIDE [USP MONOGRAPH] 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 METHACHOLINE CHLORIDE [USP MONOGRAPH] JDMF during the approval evaluation for pharmaceutical products. At the time of METHACHOLINE CHLORIDE [USP MONOGRAPH] JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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