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01 1Porton Pharma Solutions

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PharmaCompass

01

The Generic Rx Session
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPorton 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

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02

The Generic Rx Session
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI 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

AMI Lifesciences

03

The Generic Rx Session
Not Confirmed

04

The Generic Rx Session
Not Confirmed

04

The Generic Rx Session
Not Confirmed

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

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05

Msn Organics Private Ltd

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USDMF

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The Generic Rx Session
Not Confirmed

05

Msn Organics Private Ltd

Country
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The Generic Rx Session
Not Confirmed

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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Looking for 1190389-15-1 / Vibegron API manufacturers, exporters & distributors?

Vibegron manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Vibegron API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vibegron manufacturer or Vibegron supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vibegron manufacturer or Vibegron supplier.

PharmaCompass also assists you with knowing the Vibegron API Price utilized in the formulation of products. Vibegron API Price is not always fixed or binding as the Vibegron Price is obtained through a variety of data sources. The Vibegron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vibegron

Synonyms

1190389-15-1, Krp-114v, Gemtesa, Mk-4618, (s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide, M5tse03w5u

Cas Number

1190389-15-1

Unique Ingredient Identifier (UNII)

M5TSE03W5U

About Vibegron

Vibegron is a potent, selective beta-3 adrenergic receptor (3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder, a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults. It is available as oral tablets under the market name GEMTESA. Vibegron is the second beta-3 adrenergic agonist approved for the treatment of overactive bladder following [mirabegron], which was approved in 2012. Unlike mirabegron, vibegron is less likely to be associated with drug-drug interactions involving the CYP3A4, 2D6, or 2C9 enzymes.

Vibegron Manufacturers

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.

Vibegron Suppliers

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.

Vibegron USDMF

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.

Vibegron Manufacturers | Traders | Suppliers

Vibegron Manufacturers, Traders, Suppliers 1
63

We have 4 companies offering Vibegron

Get in contact with the supplier of your choice:

  1. Ami Lifesciences Private Limited
  2. Porton Pharma Solutions
  3. Aurisco Pharmaceutical
  4. HONOUR LAB LTD
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.