Axplora- The partner of choice for complex APIs.
01 1PharmaZell GmbH
02 3Nippon Protein Co., Ltd.
03 2Nippon Rika Pharmaceuticals Co., Ltd.
01 1Acetylcysteine
02 1Japanese Pharmacopoeia-acetyl-cysteine
03 1Japanese Pharmacopoeia-acetylcysteine "production-only"
04 1Outsiders regulations acetylcysteine
05 2Outsiders regulations acetylcysteine (production only)
01 1Germany
02 5Japan
Axplora- The partner of choice for complex APIs.
Registration Number : 219MF10377
Registrant's Address : ROSENHEIMER STR. 43, D-83064 RAUBLING, GERMARY
Initial Date of Registration : 2007-12-19
Latest Date of Registration : 2007-12-19
Japanese Pharmacopoeia Acetylcysteine "For manufacturing purposes only"
Registration Number : 224MF10007
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2012-01-18
Latest Date of Registration : 2012-01-18
Acetylcysteine (for manufacturing only)
Registration Number : 220MF10106
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2008-04-11
Latest Date of Registration : 2008-04-11
Acetylcysteine (for manufacturing only)
Registration Number : 218MF10577
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2006-06-15
Latest Date of Registration : 2006-06-15
Japanese Pharmacopoeia Acetylcysteine
Registration Number : 224MF10025
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2012-02-01
Latest Date of Registration : 2012-02-01
Registration Number : 217MF10061
Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2006-05-18
A Mucosil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mucosil, including repackagers and relabelers. The FDA regulates Mucosil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mucosil 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 Mucosil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mucosil supplier is an individual or a company that provides Mucosil active pharmaceutical ingredient (API) or Mucosil finished formulations upon request. The Mucosil suppliers may include Mucosil API manufacturers, exporters, distributors and traders.
click here to find a list of Mucosil 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 Mucosil Drug Master File in Japan (Mucosil JDMF) empowers Mucosil 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 Mucosil JDMF during the approval evaluation for pharmaceutical products. At the time of Mucosil 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 Mucosil suppliers with JDMF on PharmaCompass.
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