Find Glycopyrronium Tosylate manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

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US Exclusivities

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Health Canada Patents

API REF. PRICE (USD/KG)

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GLOBAL SALES INFORMATION

Annual Reports

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Regulatory FDF Prices

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MARKET PLACE

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FDF

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

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News #PharmaBuzz

Chemistry

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Also known as: Schembl15168752, Dtxsid201026596
Molecular Formula
C26H35NO6S
Molecular Weight
489.6  g/mol
InChI Key
OFNFMAIFGLDTDC-UHFFFAOYSA-M

Glycopyrronium Tosylate
1 2D Structure

Glycopyrronium Tosylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;4-methylbenzenesulfonate
2.1.2 InChI
InChI=1S/C19H28NO3.C7H8O3S/c1-20(2)13-12-17(14-20)23-18(21)19(22,16-10-6-7-11-16)15-8-4-3-5-9-15;1-6-2-4-7(5-3-6)11(8,9)10/h3-5,8-9,16-17,22H,6-7,10-14H2,1-2H3;2-5H,1H3,(H,8,9,10)/q+1;/p-1
2.1.3 InChI Key
OFNFMAIFGLDTDC-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)S(=O)(=O)[O-].C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Schembl15168752

2. Dtxsid201026596

2.3 Create Date
2008-02-11
3 Chemical and Physical Properties
Molecular Weight 489.6 g/mol
Molecular Formula C26H35NO6S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass489.21850901 g/mol
Monoisotopic Mass489.21850901 g/mol
Topological Polar Surface Area112 Ų
Heavy Atom Count34
Formal Charge0
Complexity617
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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01

Inke S.A

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Inke Company Banner

02

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Seqens Company Banner

03

Vamsi Labs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Vamsi Labs

04

Suven Life Sciences Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BioJapan
Not Confirmed
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Suven Life Sciences Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BioJapan
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
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05

Harman Finochem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BioJapan
Not Confirmed
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Harman Finochem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BioJapan
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
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USDMF

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01

Harman Finochem Ltd

India

USDMF

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BioJapan
Not Confirmed

01

BioJapan
Not Confirmed

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

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02

BioJapan
Not Confirmed

02

BioJapan
Not Confirmed

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

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Listed Suppliers

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01

Inke S.A

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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Digital Content Digital Content

Glycopyrronium Tosylate

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...

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 therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
Inke Company Banner

02

Seqens

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

Flag France
Digital Content Digital Content

Glycopyrronium Tosylate

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 ...

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 in the development, scale-up and manufacturing of drug substances from pre-clinical to commercial stages. Seqens boasts a vast portfolio of APIs and proprietary products while also developing custom solutions and ingredients for the healthcare, electronics and cosmetics industries. It operates 16 industrial plants and 9 R&D centers worldwide. Seqens possesses technologies that enable it to produce complex molecules to meet both small- and large-scale demands.
Seqens Company Banner

03

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

Flag India
Digital Content Digital Content

Glycopyrronium Tosylate

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...

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 markets(50% sales). Anti-asthma products account for 60% of sales. Vamsi adheres to high corporate governance, transparency, professionalism, & environmental protection standards. It's USFDA & EDQM certified & ISO 9001:2015, ISO 14001:2015, & ISO 45001:2018 certified. With a DSIR-certified R&D Lab, Vamsi continues to innovate & meet the pharma industry's evolving needs. Vamsi is poised to grow its globally while maintaining commitment to excellence and sustainability.
Vamsi Labs

04

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Glycopyrrolate Tosylate

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 ...

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 which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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Drugs in Development

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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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01

Eli Lilly

U.S.A
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BioJapan
Not Confirmed

Eli Lilly

U.S.A
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BioJapan
Not Confirmed

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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02

BioJapan
Not Confirmed
BioJapan
Not Confirmed

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

blank

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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03

Eli Lilly

U.S.A
arrow
BioJapan
Not Confirmed

Eli Lilly

U.S.A
arrow
BioJapan
Not Confirmed

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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FDF Dossiers

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JMC Corporation KR

South Korea
BioJapan
Not Confirmed
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JMC Corporation KR

South Korea
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BioJapan
Not Confirmed

GLYCOPYRRONIUM TOSYLATE

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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FDA Orange Book

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JOURNEY

South Korea
BioJapan
Not Confirmed
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JOURNEY

South Korea
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BioJapan
Not Confirmed

GLYCOPYRRONIUM TOSYLATE

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 :

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Patents & EXCLUSIVITIES

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Looking for / Glycopyrronium Tosylate API manufacturers, exporters & distributors?

Glycopyrronium Tosylate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Glycopyrronium Tosylate

Synonyms

Schembl15168752, Dtxsid201026596

Glycopyrronium Tosylate Manufacturers

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.

Glycopyrronium Tosylate Suppliers

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.

Glycopyrronium Tosylate USDMF

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.

Glycopyrronium Tosylate WC

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 GMP

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.

Glycopyrronium Tosylate CoA

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).

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.
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