01 1Active Pharma Inc.
02 1CADILA PHARMACEUTICALS LIMITED.
03 1Garonit Pharmaceutical, Inc.
04 5Maruishi Pharmaceutical Co., Ltd.
01 1Chlorhexidine Gluconate
02 2Chlorhexidine gluconate Sanshioeki
03 1Chlorhexidine gluconate Sanshioeki (production only)
04 2Chlorhexidine gluconate solution
05 1Japanese Pharmacopoeia chlorhexidine gluconate Sanshioeki (production only)
06 1Japanese Pharmacopoeia chlorhexidine gluconate solution (production only)
01 1India
02 6Japan
03 1U.S.A
Chlorhexidine Gluconate Solution (for manufacturing only)
Registration Number : 218MF10908
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
Chlorhexidine gluconate solution 20%
Registration Number : 305MF10128
Registrant's Address : 10 AB Madison Road, Fairfield NJ 07004 USA
Initial Date of Registration : 2023-12-06
Latest Date of Registration : 2023-12-06
Japanese Pharmacopoeia Chlorhexidine Gluconate Solution (for manufacturing only)
Registration Number : 221MF10075
Registrant's Address : 2-4-2 Imazu-Naka, Tsurumi-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2009-04-14
Latest Date of Registration : 2009-04-14
Chlorhexidine gluconate solution
Registration Number : 219MF10320
Registrant's Address : 2-4-2 Imazu-Naka, Tsurumi-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2007-10-24
Chlorhexidine gluconate solution
Registration Number : 219MF10319
Registrant's Address : 2-4-2 Imazu-Naka, Tsurumi-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2007-10-24
Chlorhexidine gluconate solution
Registration Number : 218MF10347
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Fushimi-cho 2-3-5
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2006-03-17
Chlorhexidine gluconate solution
Registration Number : 218MF10346
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Fushimi-cho 2-3-5
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2006-03-17
Japanese Pharmacopoeia Chlorhexidine Gluconate Solution (for manufacturing only)
Registration Number : 217MF10192
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-08
Latest Date of Registration : 2022-09-14
A Hibitane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hibitane, including repackagers and relabelers. The FDA regulates Hibitane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hibitane API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Hibitane supplier is an individual or a company that provides Hibitane active pharmaceutical ingredient (API) or Hibitane finished formulations upon request. The Hibitane suppliers may include Hibitane API manufacturers, exporters, distributors and traders.
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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 Hibitane Drug Master File in Japan (Hibitane JDMF) empowers Hibitane 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 Hibitane JDMF during the approval evaluation for pharmaceutical products. At the time of Hibitane 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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