Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania
02 3Chunghwa Chemical Synthesis & Biotech
03 1Apotex Fermentation Inc.
04 4Biocon
05 2BrightGene Bio-Medical Technology Co.,Ltd
06 1CKD Bio Corporation
07 1Concord Biotech
08 1Enaltec Labs Private Limited
09 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
10 1MSN Laboratories
11 1Natco Pharma
12 1ScinoPharm Taiwan, Ltd
13 1Yacht Bio-Technology
14 1Blank
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-28
Pay. Date : 2019-12-23
DMF Number : 34295
Submission : 2019-12-20
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 : 2013-09-11
Pay. Date : 2013-03-14
DMF Number : 26819
Submission : 2013-02-08
Status :
Type : II
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 : 38111
Submission : 2023-03-10
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 : 2013-10-04
Pay. Date : 2013-08-05
DMF Number : 27216
Submission : 2013-07-01
Status :
Type : II
A Everolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Everolimus, including repackagers and relabelers. The FDA regulates Everolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Everolimus 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 Everolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Everolimus supplier is an individual or a company that provides Everolimus active pharmaceutical ingredient (API) or Everolimus finished formulations upon request. The Everolimus suppliers may include Everolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Everolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Everolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Everolimus active pharmaceutical ingredient (API) in detail. Different forms of Everolimus DMFs exist exist since differing nations have different regulations, such as Everolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Everolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Everolimus USDMF includes data on Everolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Everolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Everolimus suppliers with USDMF on PharmaCompass.
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