Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1Fresenius Kabi Oncology Limited
03 1Intas Pharmaceuticals
04 1MSN Laboratories
05 1Teva Pharmaceutical Industries
01 5RIBOCICLIB SUCCINATE
01 3India
02 1Israel
03 1Taiwan
01 4Active
02 1Inactive
01 3Complete
02 2Blank
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 : 36174
Submission : 2021-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
A Ribociclib Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribociclib Succinate, including repackagers and relabelers. The FDA regulates Ribociclib Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribociclib Succinate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ribociclib Succinate supplier is an individual or a company that provides Ribociclib Succinate active pharmaceutical ingredient (API) or Ribociclib Succinate finished formulations upon request. The Ribociclib Succinate suppliers may include Ribociclib Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Ribociclib Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribociclib Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribociclib Succinate active pharmaceutical ingredient (API) in detail. Different forms of Ribociclib Succinate DMFs exist exist since differing nations have different regulations, such as Ribociclib Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribociclib Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Ribociclib Succinate USDMF includes data on Ribociclib Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribociclib Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribociclib Succinate suppliers with USDMF on PharmaCompass.
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