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API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15222
Submission : 2001-01-03
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15738
Submission : 2001-11-26
Status :
Type : II
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...
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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20136
DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20136
DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20136
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20136
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ABOUT THIS PAGE
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PharmaCompass offers a list of Torsemide 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 Torsemide manufacturer or Torsemide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Torsemide manufacturer or Torsemide supplier.
PharmaCompass also assists you with knowing the Torsemide API Price utilized in the formulation of products. Torsemide API Price is not always fixed or binding as the Torsemide Price is obtained through a variety of data sources. The Torsemide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Torasemide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Torasemide, including repackagers and relabelers. The FDA regulates Torasemide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Torasemide 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 Torasemide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Torasemide supplier is an individual or a company that provides Torasemide active pharmaceutical ingredient (API) or Torasemide finished formulations upon request. The Torasemide suppliers may include Torasemide API manufacturers, exporters, distributors and traders.
click here to find a list of Torasemide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Torasemide DMF (Drug Master File) is a document detailing the whole manufacturing process of Torasemide active pharmaceutical ingredient (API) in detail. Different forms of Torasemide DMFs exist exist since differing nations have different regulations, such as Torasemide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Torasemide DMF submitted to regulatory agencies in the US is known as a USDMF. Torasemide USDMF includes data on Torasemide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Torasemide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Torasemide suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Torasemide Drug Master File in Japan (Torasemide JDMF) empowers Torasemide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Torasemide JDMF during the approval evaluation for pharmaceutical products. At the time of Torasemide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Torasemide suppliers with JDMF 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 Torasemide Drug Master File in Korea (Torasemide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Torasemide. The MFDS reviews the Torasemide KDMF as part of the drug registration process and uses the information provided in the Torasemide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Torasemide 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 Torasemide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Torasemide suppliers with KDMF on PharmaCompass.
A Torasemide CEP of the European Pharmacopoeia monograph is often referred to as a Torasemide Certificate of Suitability (COS). The purpose of a Torasemide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Torasemide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Torasemide to their clients by showing that a Torasemide CEP has been issued for it. The manufacturer submits a Torasemide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Torasemide CEP holder for the record. Additionally, the data presented in the Torasemide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Torasemide DMF.
A Torasemide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Torasemide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Torasemide suppliers with CEP (COS) on PharmaCompass.
A Torasemide written confirmation (Torasemide WC) is an official document issued by a regulatory agency to a Torasemide manufacturer, verifying that the manufacturing facility of a Torasemide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Torasemide APIs or Torasemide finished pharmaceutical products to another nation, regulatory agencies frequently require a Torasemide WC (written confirmation) as part of the regulatory process.
click here to find a list of Torasemide 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 Torasemide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Torasemide 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 Torasemide 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 Torasemide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Torasemide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Torasemide suppliers with NDC on PharmaCompass.
Torasemide 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 Torasemide 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 Torasemide GMP manufacturer or Torasemide GMP API supplier for your needs.
A Torasemide CoA (Certificate of Analysis) is a formal document that attests to Torasemide's compliance with Torasemide specifications and serves as a tool for batch-level quality control.
Torasemide CoA mostly includes findings from lab analyses of a specific batch. For each Torasemide 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.
Torasemide may be tested according to a variety of international standards, such as European Pharmacopoeia (Torasemide EP), Torasemide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Torasemide USP).
