Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 2Chunghwa Chemical Synthesis & Biotech
02 1ABRAXIS BIOSCIENCE
03 1Abbott Laboratories
04 1Alkermes Plc
05 1Apotex Fermentation Inc.
06 1Aurisco Pharmaceutical
07 1Biocon
08 1BrightGene Bio-Medical Technology Co.,Ltd
09 1Chongqing DaXin Pharmaceutical
10 1Concord Biotech
11 1Curia
12 1Fujian Kerui Pharmaceutical Co Ltd
13 1Hangzhou Zhongmei Huadong Pharmaceutical
14 1Heilongjiang Weikang Bio-Tech
15 1Lek Pharmaceuticals
16 2Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
17 1Lonza Group
18 2Lunan Pharmaceutical
19 1Orchestra Biomed
20 1Sandoz B2B
21 1Selecta Biosciences
22 1TriviumVet
23 1WORLD JIANGSU INDUSTRY CO LTD
24 1Wyeth Pharmaceuticals Inc
25 2Zhejiang Hisun Pharmaceutical
26 1Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17399
Submission : 2004-05-20
Status :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-01-04
DMF Number : 31189
Submission : 2016-12-30
Status :
Type : II
A Sirolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sirolimus, including repackagers and relabelers. The FDA regulates Sirolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sirolimus 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 Sirolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sirolimus supplier is an individual or a company that provides Sirolimus active pharmaceutical ingredient (API) or Sirolimus finished formulations upon request. The Sirolimus suppliers may include Sirolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Sirolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sirolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Sirolimus active pharmaceutical ingredient (API) in detail. Different forms of Sirolimus DMFs exist exist since differing nations have different regulations, such as Sirolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sirolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Sirolimus USDMF includes data on Sirolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sirolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sirolimus suppliers with USDMF on PharmaCompass.
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