Synopsis
Synopsis
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CEP/COS
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JDMF
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Canada
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Australia
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South Africa
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1. Schembl15168752
2. Dtxsid201026596
| Molecular Weight | 489.6 g/mol |
|---|---|
| Molecular Formula | C26H35NO6S |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 5 |
| Exact Mass | 489.21850901 g/mol |
| Monoisotopic Mass | 489.21850901 g/mol |
| Topological Polar Surface Area | 112 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 617 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-04
Pay. Date : 2019-08-02
DMF Number : 33667
Submission : 2019-07-30
Status : Active
Type : II
Date of Issue : 2022-08-16
Valid Till : 2025-07-15
Written Confirmation Number : WC-0042N
Address of the Firm :

GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-25
Pay. Date : 2019-09-19
DMF Number : 34111
Submission : 2019-09-24
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2022-07-21
Written Confirmation Number : WC-0045A4
Address of the Firm :

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GDUFA
DMF Review : Complete
Rev. Date : 2020-03-25
Pay. Date : 2019-09-19
DMF Number : 34111
Submission : 2019-09-24
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-08-02
DMF Number : 33667
Submission : 2019-07-30
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international ma...
About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

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Details:
Journey Medical acquired global rights to QBREXZA® from Dermira in 2021. QBREXZA is a topical product approved by the U.S. Food and Drug Administration for treatment of primary axillary hyperhidrosis in adult and pediatric populations.
Lead Product(s): Glycopyrronium Tosylate,Inapplicable
Therapeutic Area: Dermatology Brand Name: Qbrexza
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Maruho
Deal Size: $7.5 million Upfront Cash: Undisclosed
Deal Type: Agreement February 11, 2022

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Lead Product(s) : Glycopyrronium Tosylate,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Maruho
Deal Size : $7.5 million
Deal Type : Agreement
QBREXZA® (Rapifort® Wipes 2.5%) Receives Manufacturing and Marketing Approval in Japan Triggerin...
Details : Journey Medical acquired global rights to QBREXZA® from Dermira in 2021. QBREXZA is a topical product approved by the U.S. Food and Drug Administration for treatment of primary axillary hyperhidrosis in adult and pediatric populations.
Product Name : Qbrexza
Product Type : Miscellaneous
Upfront Cash : Undisclosed
February 11, 2022

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Details:
QBREXZA (Rapifort® Wipes 2.5%), is a topical product approved by the U.S. Food and Drug Administration for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine-years and older) and is self-administered by patients.
Lead Product(s): Glycopyrronium Tosylate,Inapplicable
Therapeutic Area: Dermatology Brand Name: Rapifort Wipes
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Maruho
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Agreement February 11, 2022

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Lead Product(s) : Glycopyrronium Tosylate,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Maruho
Deal Size : $10.0 million
Deal Type : Agreement
QBREXZA® (Rapifort® Wipes 2.5%) Receives Manufacturing and Marketing Approval in Japan Triggerin...
Details : QBREXZA (Rapifort® Wipes 2.5%), is a topical product approved by the U.S. Food and Drug Administration for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine-years and older) and is self-administered by patients.
Product Name : Rapifort Wipes
Product Type : Miscellaneous
Upfront Cash : Undisclosed
February 11, 2022

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
QBREXZA is the only topical product to be approved by the U.S. Food and Drug Administration (FDA) for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine-years and older) and is self-administered by patients.
Lead Product(s): Glycopyrronium Tosylate,Inapplicable
Therapeutic Area: Dermatology Brand Name: Qbrexza
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Journey Medical Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 01, 2021

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Lead Product(s) : Glycopyrronium Tosylate,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Journey Medical Corporation
Deal Size : Undisclosed
Deal Type : Acquisition
Journey Medical Corporation Enters into a Definitive Agreement with Dermira to Acquire QBREXZA®
Details : QBREXZA is the only topical product to be approved by the U.S. Food and Drug Administration (FDA) for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages nine-years and older) and is self-administered by patients.
Product Name : Qbrexza
Product Type : Miscellaneous
Upfront Cash : Undisclosed
April 01, 2021

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Regulatory Info : RX
Registration Country : USA
Brand Name : QBREXZA
Dosage Form : CLOTH;TOPICAL
Dosage Strength : EQ 2.4% BASE
Packaging :
Approval Date : 2018-06-28
Application Number : 210361
Regulatory Info : RX
Registration Country : USA

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RLD : Yes
TE Code :
Brand Name : QBREXZA
Dosage Form : CLOTH;TOPICAL
Dosage Strength : EQ 2.4% BASE
Approval Date : 2018-06-28
Application Number : 210361
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
Reply
19 Apr 2021

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PharmaCompass offers a list of Glycopyrronium Tosylate 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 Glycopyrronium Tosylate manufacturer or Glycopyrronium Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glycopyrronium Tosylate manufacturer or Glycopyrronium Tosylate supplier.
PharmaCompass also assists you with knowing the Glycopyrronium Tosylate API Price utilized in the formulation of products. Glycopyrronium Tosylate API Price is not always fixed or binding as the Glycopyrronium Tosylate Price is obtained through a variety of data sources. The Glycopyrronium Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Glycopyrronium Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycopyrronium Tosylate, including repackagers and relabelers. The FDA regulates Glycopyrronium Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycopyrronium Tosylate 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 Glycopyrronium Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycopyrronium Tosylate supplier is an individual or a company that provides Glycopyrronium Tosylate active pharmaceutical ingredient (API) or Glycopyrronium Tosylate finished formulations upon request. The Glycopyrronium Tosylate suppliers may include Glycopyrronium Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycopyrronium Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycopyrronium Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycopyrronium Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Glycopyrronium Tosylate DMFs exist exist since differing nations have different regulations, such as Glycopyrronium Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycopyrronium Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycopyrronium Tosylate USDMF includes data on Glycopyrronium Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycopyrronium Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycopyrronium Tosylate suppliers with USDMF on PharmaCompass.
A Glycopyrronium Tosylate written confirmation (Glycopyrronium Tosylate WC) is an official document issued by a regulatory agency to a Glycopyrronium Tosylate manufacturer, verifying that the manufacturing facility of a Glycopyrronium Tosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glycopyrronium Tosylate APIs or Glycopyrronium Tosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Glycopyrronium Tosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Glycopyrronium Tosylate suppliers with Written Confirmation (WC) on PharmaCompass.
Glycopyrronium Tosylate 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 Glycopyrronium Tosylate 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 Glycopyrronium Tosylate GMP manufacturer or Glycopyrronium Tosylate GMP API supplier for your needs.
A Glycopyrronium Tosylate CoA (Certificate of Analysis) is a formal document that attests to Glycopyrronium Tosylate's compliance with Glycopyrronium Tosylate specifications and serves as a tool for batch-level quality control.
Glycopyrronium Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Glycopyrronium Tosylate 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.
Glycopyrronium Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycopyrronium Tosylate EP), Glycopyrronium Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycopyrronium Tosylate USP).