Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Ami Lifesciences Private Limited
03 1Aurisco Pharmaceutical
04 1HONOUR LAB LTD
05 1Blank
01 5VIBEGRON
01 2China
02 2India
03 1Blank
01 5Active
01 4Complete
02 1Blank
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40275
Submission : 2024-08-01
Status : Active
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-31
Pay. Date : 2024-06-13
DMF Number : 39538
Submission : 2024-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-16
Pay. Date : 2024-07-19
DMF Number : 40068
Submission : 2024-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-12
Pay. Date : 2024-09-24
DMF Number : 40333
Submission : 2024-09-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-22
Pay. Date : 2024-09-26
DMF Number : 40304
Submission : 2024-09-24
Status : Active
Type : II
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A Vibegron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vibegron, including repackagers and relabelers. The FDA regulates Vibegron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vibegron 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 Vibegron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vibegron supplier is an individual or a company that provides Vibegron active pharmaceutical ingredient (API) or Vibegron finished formulations upon request. The Vibegron suppliers may include Vibegron API manufacturers, exporters, distributors and traders.
click here to find a list of Vibegron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vibegron DMF (Drug Master File) is a document detailing the whole manufacturing process of Vibegron active pharmaceutical ingredient (API) in detail. Different forms of Vibegron DMFs exist exist since differing nations have different regulations, such as Vibegron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vibegron DMF submitted to regulatory agencies in the US is known as a USDMF. Vibegron USDMF includes data on Vibegron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vibegron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vibegron suppliers with USDMF on PharmaCompass.
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