01 1FDC LIMITED.
01 1Bromhexine Hydrochloride
01 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
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PharmaCompass offers a list of Bromhexine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bromhexine Hydrochloride manufacturer or Bromhexine Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Bromhexine Hydrochloride API Price utilized in the formulation of products. Bromhexine Hydrochloride API Price is not always fixed or binding as the Bromhexine Hydrochloride Price is obtained through a variety of data sources. The Bromhexine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride, including repackagers and relabelers. The FDA regulates 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine 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.
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A 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride supplier is an individual or a company that provides 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride active pharmaceutical ingredient (API) or 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride finished formulations upon request. The 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride suppliers may include 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride 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 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride Drug Master File in Japan (2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride JDMF) empowers 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine 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 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride 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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