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Chemistry

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Also known as: Colestid, Cholestabyl, 37296-80-3, Colestipol hydrochloride [usan:usp], Lestid, Flavored colestid
Molecular Formula
C8H24ClN5
Molecular Weight
225.76  g/mol
InChI Key
GACQNVJDWUAPFY-UHFFFAOYSA-N

Colestipol
Highly crosslinked and insoluble basic anion exchange resin used as anticholesteremic. It may also may reduce triglyceride levels.
1 2D Structure

Colestipol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;hydrochloride
2.1.2 InChI
InChI=1S/C8H23N5.ClH/c9-1-3-11-5-7-13-8-6-12-4-2-10;/h11-13H,1-10H2;1H
2.1.3 InChI Key
GACQNVJDWUAPFY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C(CNCCNCCNCCN)N.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Colestid

2. Colestipol

3. Colestipol Hcl

4. Hcl, Colestipol

5. Hydrochloride, Colestipol

6. U 26,597 A

7. U-26,597 A

8. U26,597 A

2.2.2 Depositor-Supplied Synonyms

1. Colestid

2. Cholestabyl

3. 37296-80-3

4. Colestipol Hydrochloride [usan:usp]

5. Lestid

6. Flavored Colestid

7. N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;hydrochloride

8. U-26597a

9. Unii-x7d10k905g

10. Tetraethylenepentamine Hcl

11. Copolymer Of Diethylenetriamine And 1-chloro-2,3-epoxypropane, Hydrochloride (with Approximately 1 Out Of 5 Amine Nitrogens Protonated)

12. Schembl284758

13. Dtxsid40190737

14. X7d10k905g

15. Ft-0749664

2.3 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 225.76 g/mol
Molecular Formula C8H24ClN5
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count5
Rotatable Bond Count10
Exact Mass225.1720235 g/mol
Monoisotopic Mass225.1720235 g/mol
Topological Polar Surface Area88.1 Ų
Heavy Atom Count14
Formal Charge0
Complexity78.6
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameColestipol hydrochloride
Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
Active IngredientColestipol hydrochloride
Dosage FormTablet; Granule
RouteOral
Strength1gm; 5gm/scoopful; 5gm/packet
Market StatusPrescription
CompanyImpax Labs

2 of 4  
Drug NameFlavored colestid
Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
Active IngredientColestipol hydrochloride
Dosage FormGranule
RouteOral
Strength5gm/scoopful; 5gm/packet
Market StatusPrescription
CompanyPharmacia And Upjohn

3 of 4  
Drug NameColestipol hydrochloride
Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
Active IngredientColestipol hydrochloride
Dosage FormTablet; Granule
RouteOral
Strength1gm; 5gm/scoopful; 5gm/packet
Market StatusPrescription
CompanyImpax Labs

4 of 4  
Drug NameFlavored colestid
Drug LabelCOLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and...
Active IngredientColestipol hydrochloride
Dosage FormGranule
RouteOral
Strength5gm/scoopful; 5gm/packet
Market StatusPrescription
CompanyPharmacia And Upjohn

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anion Exchange Resins

High-molecular-weight insoluble polymers that contain functional cationic groups capable of undergoing exchange reactions with anions. (See all compounds classified as Anion Exchange Resins.)


Hypolipidemic Agents

Substances that lower the levels of certain LIPIDS in the BLOOD. They are used to treat HYPERLIPIDEMIAS. (See all compounds classified as Hypolipidemic Agents.)


Sequestering Agents

Compounds that bind to and reduce the biological availability of a chemical or pharmaceutical agent. (See all compounds classified as Sequestering Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Bile-acid Binding Activity [MoA]; Bile Acid Sequestrant [EPC]

Listed Suppliers

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01

Apicore

India
AGGSpend
Not Confirmed
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Apicore

India
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AGGSpend
Not Confirmed

Colestipol

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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02

AGGSpend
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Colestipol

About the Company : Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspecti...

Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspections from regulatory authorities around the world, Formosa now provides CDMO service extending from APIs and ADCs (Antibody Drug Conjugates) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Formosa Laboratories is able to offer full-service GMP manufacturing for drug substance, ADCs and drug product with its API and injectable facilities that accommodates small molecules, biologics and ADCs etc.
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03

Raks Pharma

India
AGGSpend
Not Confirmed
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Raks Pharma

India
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AGGSpend
Not Confirmed

Colestipol

About the Company : Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuti...

Founded by a group of highly committed Technocrats in year 2009, today Raks Pharma is a partner of choice for pharmaceutical companies across the globe to source Active Pharmaceuticals Ingredients and their intermediates. Till date the company has invested around US $ 50M and has filed 23 US DMFs and 1 CEP with US and European Authority's respectively. The manufacturing facility is also approved by USFDA and WHO. We at Raks are dedicated to develop and manufacture active pharmaceutical ingredients and intermediates. We are committed to create value through intellectual property, quality systems and customer relation across the globe.
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04

Viatris

U.S.A
AGGSpend
Not Confirmed
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Viatris

U.S.A
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AGGSpend
Not Confirmed

Colestipol

About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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05

AGGSpend
Not Confirmed
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Colestipol

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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API Reference Price

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29-Jan-2022
27-Jun-2025
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DOSAGE - GRANULE;ORAL - 5GM/PACKET

USFDA APPLICATION NUMBER - 17563

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DOSAGE - TABLET;ORAL - 1GM

USFDA APPLICATION NUMBER - 20222

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ABOUT THIS PAGE

Looking for 37296-80-3 / Colestipol API manufacturers, exporters & distributors?

Colestipol manufacturers, exporters & distributors 1

58

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.

API | Excipient name

Colestipol

Synonyms

Colestid, Cholestabyl, 37296-80-3, Colestipol hydrochloride [usan:usp], Lestid, Flavored colestid

Cas Number

37296-80-3

About Colestipol

Highly crosslinked and insoluble basic anion exchange resin used as anticholesteremic. It may also may reduce triglyceride levels.

Colestipol Manufacturers

A Colestipol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colestipol, including repackagers and relabelers. The FDA regulates Colestipol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colestipol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Colestipol Suppliers

A Colestipol supplier is an individual or a company that provides Colestipol active pharmaceutical ingredient (API) or Colestipol finished formulations upon request. The Colestipol suppliers may include Colestipol API manufacturers, exporters, distributors and traders.

click here to find a list of Colestipol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Colestipol USDMF

A Colestipol DMF (Drug Master File) is a document detailing the whole manufacturing process of Colestipol active pharmaceutical ingredient (API) in detail. Different forms of Colestipol DMFs exist exist since differing nations have different regulations, such as Colestipol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Colestipol DMF submitted to regulatory agencies in the US is known as a USDMF. Colestipol USDMF includes data on Colestipol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colestipol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Colestipol suppliers with USDMF on PharmaCompass.

Colestipol NDC

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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Colestipol API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Colestipol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colestipol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Colestipol suppliers with NDC on PharmaCompass.

Colestipol GMP

Colestipol 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 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 GMP manufacturer or Colestipol GMP API supplier for your needs.

Colestipol CoA

A Colestipol CoA (Certificate of Analysis) is a formal document that attests to Colestipol's compliance with Colestipol specifications and serves as a tool for batch-level quality control.

Colestipol CoA mostly includes findings from lab analyses of a specific batch. For each Colestipol 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Colestipol EP), Colestipol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colestipol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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