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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
Lead Product(s) : Fesoterodine,Inapplicable
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.
Product Name : Fesoterodine Fumarate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 07, 2022
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
CAS Number : 156755-23-6
End Use API : Fesoterodine
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Methyl (±)- 3-(2-(benzyloxy)-5-bromophenyl) -3-ph...
CAS Number : 156755-24-7
End Use API : Fesoterodine
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
(±)-3-(2-(Benzyloxy)-5-bromophenyl)-3phenylpropan...
CAS Number : 156755-25-8
End Use API : Fesoterodine
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
3-[(1 -phenyl propyl]-4 (phenylmethoxy)benzoic aci...
CAS Number : 156755-35-0
End Use API : Fesoterodine
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG
USFDA APPLICATION NUMBER - 22030
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG
USFDA APPLICATION NUMBER - 22030
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26 Feb 2019
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ABOUT THIS PAGE
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PharmaCompass offers a list of Fesoterodine 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 Fesoterodine manufacturer or Fesoterodine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fesoterodine manufacturer or Fesoterodine supplier.
PharmaCompass also assists you with knowing the Fesoterodine API Price utilized in the formulation of products. Fesoterodine API Price is not always fixed or binding as the Fesoterodine Price is obtained through a variety of data sources. The Fesoterodine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fesoterodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fesoterodine, including repackagers and relabelers. The FDA regulates Fesoterodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fesoterodine 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 Fesoterodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fesoterodine supplier is an individual or a company that provides Fesoterodine active pharmaceutical ingredient (API) or Fesoterodine finished formulations upon request. The Fesoterodine suppliers may include Fesoterodine API manufacturers, exporters, distributors and traders.
click here to find a list of Fesoterodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fesoterodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fesoterodine active pharmaceutical ingredient (API) in detail. Different forms of Fesoterodine DMFs exist exist since differing nations have different regulations, such as Fesoterodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fesoterodine DMF submitted to regulatory agencies in the US is known as a USDMF. Fesoterodine USDMF includes data on Fesoterodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fesoterodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fesoterodine 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 Fesoterodine Drug Master File in Korea (Fesoterodine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fesoterodine. The MFDS reviews the Fesoterodine KDMF as part of the drug registration process and uses the information provided in the Fesoterodine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fesoterodine 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 Fesoterodine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fesoterodine suppliers with KDMF on PharmaCompass.
A Fesoterodine written confirmation (Fesoterodine WC) is an official document issued by a regulatory agency to a Fesoterodine manufacturer, verifying that the manufacturing facility of a Fesoterodine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fesoterodine APIs or Fesoterodine finished pharmaceutical products to another nation, regulatory agencies frequently require a Fesoterodine WC (written confirmation) as part of the regulatory process.
click here to find a list of Fesoterodine suppliers with Written Confirmation (WC) 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 Fesoterodine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fesoterodine 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 Fesoterodine 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 Fesoterodine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fesoterodine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fesoterodine suppliers with NDC on PharmaCompass.
Fesoterodine 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 Fesoterodine 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 Fesoterodine GMP manufacturer or Fesoterodine GMP API supplier for your needs.
A Fesoterodine CoA (Certificate of Analysis) is a formal document that attests to Fesoterodine's compliance with Fesoterodine specifications and serves as a tool for batch-level quality control.
Fesoterodine CoA mostly includes findings from lab analyses of a specific batch. For each Fesoterodine 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.
Fesoterodine may be tested according to a variety of international standards, such as European Pharmacopoeia (Fesoterodine EP), Fesoterodine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fesoterodine USP).
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