Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1Fine Organics
03 1Maithri Drugs
04 1Maprimed
05 1Synthon Pharmaceuticals
06 1Wacker Chemie AG
01 21,3-DICHLOROACETONE
02 4OZANIMOD HYDROCHLORIDE
01 1Argentina
02 1Germany
03 1India
04 1Netherlands
05 1Taiwan
06 1United Kingdom
01 4Active
02 2Inactive
01 2Complete
02 4Blank
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 : 37597
Submission : 2022-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8531
Submission : 1990-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37015
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-10
Pay. Date : 2023-09-15
DMF Number : 38622
Submission : 2023-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-22
Pay. Date : 2023-11-17
DMF Number : 38668
Submission : 2023-11-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8462
Submission : 1990-02-22
Status : Inactive
Type : II
A Ozanimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ozanimod, including repackagers and relabelers. The FDA regulates Ozanimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ozanimod 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 Ozanimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ozanimod supplier is an individual or a company that provides Ozanimod active pharmaceutical ingredient (API) or Ozanimod finished formulations upon request. The Ozanimod suppliers may include Ozanimod API manufacturers, exporters, distributors and traders.
click here to find a list of Ozanimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ozanimod DMF (Drug Master File) is a document detailing the whole manufacturing process of Ozanimod active pharmaceutical ingredient (API) in detail. Different forms of Ozanimod DMFs exist exist since differing nations have different regulations, such as Ozanimod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ozanimod DMF submitted to regulatory agencies in the US is known as a USDMF. Ozanimod USDMF includes data on Ozanimod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ozanimod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ozanimod suppliers with USDMF on PharmaCompass.
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