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API SUPPLIERS
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USDMF
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DOSAGE - GRANULE;ORAL - 5GM/PACKET
USFDA APPLICATION NUMBER - 17563
DOSAGE - TABLET;ORAL - 1GM
USFDA APPLICATION NUMBER - 20222
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
54
PharmaCompass offers a list of Colestipol 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 Colestipol manufacturer or Colestipol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Colestipol manufacturer or Colestipol supplier.
PharmaCompass also assists you with knowing the Colestipol API Price utilized in the formulation of products. Colestipol API Price is not always fixed or binding as the Colestipol Price is obtained through a variety of data sources. The Colestipol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A COLESTIPOL HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COLESTIPOL HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates COLESTIPOL HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COLESTIPOL 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 COLESTIPOL HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A COLESTIPOL HYDROCHLORIDE supplier is an individual or a company that provides COLESTIPOL HYDROCHLORIDE active pharmaceutical ingredient (API) or COLESTIPOL HYDROCHLORIDE finished formulations upon request. The COLESTIPOL HYDROCHLORIDE suppliers may include COLESTIPOL HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of COLESTIPOL HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A COLESTIPOL HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of COLESTIPOL HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of COLESTIPOL HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as COLESTIPOL HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A COLESTIPOL HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. COLESTIPOL HYDROCHLORIDE USDMF includes data on COLESTIPOL HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The COLESTIPOL HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of COLESTIPOL HYDROCHLORIDE 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 COLESTIPOL HYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for COLESTIPOL 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 COLESTIPOL 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 COLESTIPOL HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a COLESTIPOL HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of COLESTIPOL HYDROCHLORIDE suppliers with NDC on PharmaCompass.
COLESTIPOL 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 COLESTIPOL 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 COLESTIPOL HYDROCHLORIDE GMP manufacturer or COLESTIPOL HYDROCHLORIDE GMP API supplier for your needs.
A COLESTIPOL HYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to COLESTIPOL HYDROCHLORIDE's compliance with COLESTIPOL HYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
COLESTIPOL HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each COLESTIPOL 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.
COLESTIPOL HYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (COLESTIPOL HYDROCHLORIDE EP), COLESTIPOL HYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (COLESTIPOL HYDROCHLORIDE USP).
