Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1PCAS S.A.
02 1Olon S. p. A.
01 1Glycopyrronium Bromide
02 1Glycopyrronium bromide
01 1France
02 1Italy
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Glycopyrronium bromide "For manufacturing purposes only"
Registration Number : 230MF10066
Registrant's Address : 21,chemin de la Sauvegarde 21 Ecully Parc - CS 33167 69134 Ecully Cedex France
Initial Date of Registration : 2018-05-21
Latest Date of Registration : 2019-05-07
Registration Number : 304MF10139
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2022-10-05
Latest Date of Registration : 2022-10-05
A Glycopyrrolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrrolate, including repackagers and relabelers. The FDA regulates Glycopyrrolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrrolate 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 Glycopyrrolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrrolate supplier is an individual or a company that provides Glycopyrrolate active pharmaceutical ingredient (API) or Glycopyrrolate finished formulations upon request. The Glycopyrrolate suppliers may include Glycopyrrolate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrrolate 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 Glycopyrrolate Drug Master File in Japan (Glycopyrrolate JDMF) empowers Glycopyrrolate 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 Glycopyrrolate JDMF during the approval evaluation for pharmaceutical products. At the time of Glycopyrrolate 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 Glycopyrrolate suppliers with JDMF on PharmaCompass.
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