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API SUPPLIERS
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USDMF
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Canada
Brand Name : ZAROXOLYN
Dosage Form : TABLET
Dosage Strength : 2.5MG
Packaging : 100
Approval Date :
Application Number : 888400
Regulatory Info :
Registration Country : Canada
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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**Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 17386
DOSAGE - TABLET;ORAL - 2.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17386
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**Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 17386
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Metolazone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metolazone, including repackagers and relabelers. The FDA regulates Metolazone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metolazone 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 Metolazone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Metolazone supplier is an individual or a company that provides Metolazone active pharmaceutical ingredient (API) or Metolazone finished formulations upon request. The Metolazone suppliers may include Metolazone API manufacturers, exporters, distributors and traders.
click here to find a list of Metolazone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Metolazone DMF (Drug Master File) is a document detailing the whole manufacturing process of Metolazone active pharmaceutical ingredient (API) in detail. Different forms of Metolazone DMFs exist exist since differing nations have different regulations, such as Metolazone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Metolazone DMF submitted to regulatory agencies in the US is known as a USDMF. Metolazone USDMF includes data on Metolazone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metolazone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Metolazone suppliers with USDMF on PharmaCompass.
A Metolazone CEP of the European Pharmacopoeia monograph is often referred to as a Metolazone Certificate of Suitability (COS). The purpose of a Metolazone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Metolazone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Metolazone to their clients by showing that a Metolazone CEP has been issued for it. The manufacturer submits a Metolazone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Metolazone CEP holder for the record. Additionally, the data presented in the Metolazone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Metolazone DMF.
A Metolazone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Metolazone 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 Metolazone suppliers with CEP (COS) on PharmaCompass.
A Metolazone written confirmation (Metolazone WC) is an official document issued by a regulatory agency to a Metolazone manufacturer, verifying that the manufacturing facility of a Metolazone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metolazone APIs or Metolazone finished pharmaceutical products to another nation, regulatory agencies frequently require a Metolazone WC (written confirmation) as part of the regulatory process.
click here to find a list of Metolazone 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 Metolazone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Metolazone 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 Metolazone 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 Metolazone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Metolazone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Metolazone suppliers with NDC on PharmaCompass.
Metolazone 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 Metolazone 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 Metolazone GMP manufacturer or Metolazone GMP API supplier for your needs.
A Metolazone CoA (Certificate of Analysis) is a formal document that attests to Metolazone's compliance with Metolazone specifications and serves as a tool for batch-level quality control.
Metolazone CoA mostly includes findings from lab analyses of a specific batch. For each Metolazone 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.
Metolazone may be tested according to a variety of international standards, such as European Pharmacopoeia (Metolazone EP), Metolazone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metolazone USP).
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