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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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AMI Lifesciences is Driven by Chemistry. Powered by People.
KDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Suanfarma, at the Core of a Better Life.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
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USDMF
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 :
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 :
Type : II
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2024-11-07
Registration Number : 434-69-ND
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi – 391 45...
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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
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Drugs in Development
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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
(1R,2R)-2-amino-6-(4-nitrophenyl)-1-phenylhex-5- y...
CAS Number : 1628836-08-7
End Use API : Vibegron
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
(6S)-4,6,7,8-tetrahydro-4- oxo-Pyrrolo[1,2- a]pyri...
CAS Number : 1190392-22-3
End Use API : Vibegron
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
Sodium(S)-4-oxo-4,6,7,8- tetrahydropyrrolo[1,2- a]...
CAS Number : 1421271-01-3
End Use API : Vibegron
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
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ABOUT THIS PAGE
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Vibegron Drug Master File in Korea (Vibegron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vibegron. The MFDS reviews the Vibegron KDMF as part of the drug registration process and uses the information provided in the Vibegron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vibegron KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Vibegron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vibegron suppliers with KDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vibegron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vibegron API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Vibegron as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Vibegron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vibegron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vibegron suppliers with NDC on PharmaCompass.
Vibegron Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Vibegron GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vibegron GMP manufacturer or Vibegron GMP API supplier for your needs.
A Vibegron CoA (Certificate of Analysis) is a formal document that attests to Vibegron's compliance with Vibegron specifications and serves as a tool for batch-level quality control.
Vibegron CoA mostly includes findings from lab analyses of a specific batch. For each Vibegron CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Vibegron may be tested according to a variety of international standards, such as European Pharmacopoeia (Vibegron EP), Vibegron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vibegron USP).
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