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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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API
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Europe
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Canada
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US Medicaid
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API SUPPLIERS
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Direct Compression
Thickeners and Stabilizers
Co-Processed Excipients
Granulation
Lubricants & Glidants
Disintegrants & Superdisintegrants
Controlled & Modified Release
Solubilizers
Chewable & Orodispersible Aids
Coating Systems & Additives
Taste Masking
Emulsifying Agents
Parenteral
Film Formers & Plasticizers
API Stability Enhancers
Rheology Modifiers
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Quinidine Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinidine Gluconate, including repackagers and relabelers. The FDA regulates Quinidine Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinidine Gluconate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Quinidine Gluconate supplier is an individual or a company that provides Quinidine Gluconate active pharmaceutical ingredient (API) or Quinidine Gluconate finished formulations upon request. The Quinidine Gluconate suppliers may include Quinidine Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Quinidine Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinidine Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinidine Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Quinidine Gluconate DMFs exist exist since differing nations have different regulations, such as Quinidine Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinidine Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Quinidine Gluconate USDMF includes data on Quinidine Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinidine Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinidine Gluconate suppliers with USDMF 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 Quinidine Gluconate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Quinidine Gluconate 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 Quinidine Gluconate 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 Quinidine Gluconate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quinidine Gluconate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Quinidine Gluconate suppliers with NDC on PharmaCompass.
Quinidine Gluconate 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 Quinidine Gluconate 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 Quinidine Gluconate GMP manufacturer or Quinidine Gluconate GMP API supplier for your needs.
A Quinidine Gluconate CoA (Certificate of Analysis) is a formal document that attests to Quinidine Gluconate's compliance with Quinidine Gluconate specifications and serves as a tool for batch-level quality control.
Quinidine Gluconate CoA mostly includes findings from lab analyses of a specific batch. For each Quinidine Gluconate 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.
Quinidine Gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (Quinidine Gluconate EP), Quinidine Gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quinidine Gluconate USP).
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