Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1ALP Pharm
03 1Cipla
01 3DIFELIKEFALIN ACETATE
01 1China
02 1India
03 1Taiwan
01 3Active
01 3Blank
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 : 38511
Submission : 2023-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38645
Submission : 2023-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37712
Submission : 2023-01-25
Status : Active
Type : II
A Difelikefalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difelikefalin, including repackagers and relabelers. The FDA regulates Difelikefalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difelikefalin 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 Difelikefalin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difelikefalin supplier is an individual or a company that provides Difelikefalin active pharmaceutical ingredient (API) or Difelikefalin finished formulations upon request. The Difelikefalin suppliers may include Difelikefalin API manufacturers, exporters, distributors and traders.
click here to find a list of Difelikefalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difelikefalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Difelikefalin active pharmaceutical ingredient (API) in detail. Different forms of Difelikefalin DMFs exist exist since differing nations have different regulations, such as Difelikefalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difelikefalin DMF submitted to regulatory agencies in the US is known as a USDMF. Difelikefalin USDMF includes data on Difelikefalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difelikefalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difelikefalin suppliers with USDMF on PharmaCompass.
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