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JDMF
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KDMF
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VMF
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Canada
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API SUPPLIERS
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USDMF
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-12
Pay. Date : 2020-06-05
DMF Number : 15174
Submission : 2000-12-04
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12374
Submission : 1997-02-24
Status :
Type : II
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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**Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 17783
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**Federal Regist...DOSAGE - TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 17783
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**Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 17783
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 20329
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG
USFDA APPLICATION NUMBER - 20329
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG
USFDA APPLICATION NUMBER - 20329
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Glipizide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glipizide, including repackagers and relabelers. The FDA regulates Glipizide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glipizide 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 Glipizide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glipizide supplier is an individual or a company that provides Glipizide active pharmaceutical ingredient (API) or Glipizide finished formulations upon request. The Glipizide suppliers may include Glipizide API manufacturers, exporters, distributors and traders.
click here to find a list of Glipizide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glipizide DMF (Drug Master File) is a document detailing the whole manufacturing process of Glipizide active pharmaceutical ingredient (API) in detail. Different forms of Glipizide DMFs exist exist since differing nations have different regulations, such as Glipizide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glipizide DMF submitted to regulatory agencies in the US is known as a USDMF. Glipizide USDMF includes data on Glipizide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glipizide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glipizide suppliers with USDMF on PharmaCompass.
A Glipizide CEP of the European Pharmacopoeia monograph is often referred to as a Glipizide Certificate of Suitability (COS). The purpose of a Glipizide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glipizide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glipizide to their clients by showing that a Glipizide CEP has been issued for it. The manufacturer submits a Glipizide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glipizide CEP holder for the record. Additionally, the data presented in the Glipizide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glipizide DMF.
A Glipizide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glipizide 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 Glipizide suppliers with CEP (COS) on PharmaCompass.
A Glipizide written confirmation (Glipizide WC) is an official document issued by a regulatory agency to a Glipizide manufacturer, verifying that the manufacturing facility of a Glipizide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glipizide APIs or Glipizide finished pharmaceutical products to another nation, regulatory agencies frequently require a Glipizide WC (written confirmation) as part of the regulatory process.
click here to find a list of Glipizide 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 Glipizide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glipizide 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 Glipizide 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 Glipizide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glipizide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glipizide suppliers with NDC on PharmaCompass.
Glipizide 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 Glipizide 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 Glipizide GMP manufacturer or Glipizide GMP API supplier for your needs.
A Glipizide CoA (Certificate of Analysis) is a formal document that attests to Glipizide's compliance with Glipizide specifications and serves as a tool for batch-level quality control.
Glipizide CoA mostly includes findings from lab analyses of a specific batch. For each Glipizide 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.
Glipizide may be tested according to a variety of international standards, such as European Pharmacopoeia (Glipizide EP), Glipizide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glipizide USP).
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