01 1FDC LIMITED.
02 1Sanyo Chemical Research Institute Co., Ltd.
01 1Bromhexine Hydrochloride
02 1Bromhexine hydrochloride
01 1Gabon
02 1India
Registration Number : 305MF10115
Registrant's Address : 142-48,s,v,road,jogeshwari(w),mumbai-400 102 India
Initial Date of Registration : 2023-10-12
Latest Date of Registration : 2023-10-12
Registration Number : 227MF10252
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2015-10-09
Latest Date of Registration : 2023-11-01
A Bromhexine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromhexine Hydrochloride, including repackagers and relabelers. The FDA regulates Bromhexine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromhexine 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 Bromhexine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromhexine Hydrochloride supplier is an individual or a company that provides Bromhexine Hydrochloride active pharmaceutical ingredient (API) or Bromhexine Hydrochloride finished formulations upon request. The Bromhexine Hydrochloride suppliers may include Bromhexine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bromhexine 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 Bromhexine Hydrochloride Drug Master File in Japan (Bromhexine Hydrochloride JDMF) empowers Bromhexine 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 Bromhexine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bromhexine 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 Bromhexine Hydrochloride suppliers with JDMF on PharmaCompass.
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