01 1APOTECNIA S. A.
02 1Amino Chemicals Ltd.
03 1Aurobindo Pharma Limited
04 4Derivados Quimicos sau
05 1ERCROS INDUSTRIAL,S. A.
06 1GEDEON RICHTER Plc.
07 1Hetero Labs Limited
08 1INIST ST CO. , LTD.
09 1Permakem Asia Co., Ltd.
10 1Qilu Pharmaceutical Co. , Ltd.
11 1Shandong Anhong Pharmaceutical Co. , Ltd.
12 1SperaNexus Inc.
13 1Synergene Active Ingredients Pvt. Ltd.
14 1Uquifa Mexico, S. A. de C. V.
15 1Wavelength Enterprises Ltd
A Terbinafine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbinafine Hydrochloride, including repackagers and relabelers. The FDA regulates Terbinafine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbinafine 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 Terbinafine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terbinafine Hydrochloride supplier is an individual or a company that provides Terbinafine Hydrochloride active pharmaceutical ingredient (API) or Terbinafine Hydrochloride finished formulations upon request. The Terbinafine Hydrochloride suppliers may include Terbinafine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Terbinafine 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 Terbinafine Hydrochloride Drug Master File in Japan (Terbinafine Hydrochloride JDMF) empowers Terbinafine 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 Terbinafine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Terbinafine 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 Terbinafine Hydrochloride suppliers with JDMF on PharmaCompass.
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