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USDMF
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 200678
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE
USFDA APPLICATION NUMBER - 200678
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE
USFDA APPLICATION NUMBER - 200678
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 22350
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 22350
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ABOUT THIS PAGE
A Saxagliptin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Saxagliptin Hydrochloride, including repackagers and relabelers. The FDA regulates Saxagliptin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Saxagliptin Hydrochloride supplier is an individual or a company that provides Saxagliptin Hydrochloride active pharmaceutical ingredient (API) or Saxagliptin Hydrochloride finished formulations upon request. The Saxagliptin Hydrochloride suppliers may include Saxagliptin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Saxagliptin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Saxagliptin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Saxagliptin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Saxagliptin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Saxagliptin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Saxagliptin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Saxagliptin Hydrochloride USDMF includes data on Saxagliptin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Saxagliptin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Saxagliptin Hydrochloride suppliers with USDMF on PharmaCompass.
A Saxagliptin Hydrochloride written confirmation (Saxagliptin Hydrochloride WC) is an official document issued by a regulatory agency to a Saxagliptin Hydrochloride manufacturer, verifying that the manufacturing facility of a Saxagliptin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Saxagliptin Hydrochloride APIs or Saxagliptin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Saxagliptin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Saxagliptin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Saxagliptin Hydrochloride suppliers with NDC on PharmaCompass.
Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride GMP manufacturer or Saxagliptin Hydrochloride GMP API supplier for your needs.
A Saxagliptin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Saxagliptin Hydrochloride's compliance with Saxagliptin Hydrochloride specifications and serves as a tool for batch-level quality control.
Saxagliptin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Saxagliptin Hydrochloride 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.
Saxagliptin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Saxagliptin Hydrochloride EP), Saxagliptin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Saxagliptin Hydrochloride USP).
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