Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech Co. , Ltd.
02 1TAPI Czech Industries s. r. o.
03 1Astellas Pharma Inc.
04 1CERES F&D Inc.
05 1CKD Bio Corporation
06 1CONCORD BIOTECH LIMITED.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Registration Number : 224MF10125
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2012-07-13
Latest Date of Registration : 2013-05-20
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registration Number : 222MF10265
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2010-12-08
Latest Date of Registration : 2015-12-11
A Tacrolimus Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tacrolimus Monohydrate, including repackagers and relabelers. The FDA regulates Tacrolimus Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tacrolimus Monohydrate 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 Tacrolimus Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tacrolimus Monohydrate supplier is an individual or a company that provides Tacrolimus Monohydrate active pharmaceutical ingredient (API) or Tacrolimus Monohydrate finished formulations upon request. The Tacrolimus Monohydrate suppliers may include Tacrolimus Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tacrolimus Monohydrate 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 Tacrolimus Monohydrate Drug Master File in Japan (Tacrolimus Monohydrate JDMF) empowers Tacrolimus Monohydrate 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 Tacrolimus Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Tacrolimus Monohydrate 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 Tacrolimus Monohydrate suppliers with JDMF on PharmaCompass.
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