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List of Drug Master Files (DMF) of Colesevelam Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aurobindo Pharma Limited (1)

02 CTX Lifesciences (1)

03 Emcure Pharmaceuticals (1)

04 Formosa Laboratories (2)

05 Ind Swift Laboratories Limited (1)

06 Lupin Ltd (1)

07 Navinta (1)

08 Royal DSM (1)

09 Solara Active Pharma Sciences (1)

10 Waterstone Pharmaceuticals Inc. (1)

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01 COLESEVELAM HYDROCHLORIDE (11)

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01 China (1)

02 India (6)

03 Netherlands (1)

04 Taiwan (2)

05 U.S.A (1)

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01 Active (8)

02 Inactive (3)

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01 Complete (6)

02 Blank (5)

URL Supplier Web Content
31095
Active
2016-11-04
Complete
2017-01-30
2016-10-28
II
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URL Supplier Web Content
26934
Active
2013-03-31
Complete
2014-02-12
2013-12-05
II
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30001
Active
2015-11-13
Complete
2016-01-13
2015-11-16
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URL Supplier Web Content
22870
Active
2009-06-16
Complete
2013-05-01
2013-04-18
II
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URL Supplier Web Content
26813
Inactive
2013-02-05
N/A
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URL Supplier Web Content
23333
Inactive
2010-04-06
N/A
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URL Supplier Web Content
38605
Active
2023-07-18
N/A
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URL Supplier Web Content
28945
Active
2014-12-19
Complete
2015-08-04
2015-01-14
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URL Supplier Web Content
23378
Active
2009-12-16
Complete
2013-03-07
2013-02-20
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URL Supplier Web Content
37431
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2022-12-22
N/A
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Looking for 182815-43-6 / Colesevelam Hydrochloride API manufacturers, exporters & distributors?

Colesevelam Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Colesevelam Hydrochloride 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 Colesevelam Hydrochloride manufacturer or Colesevelam Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Colesevelam Hydrochloride manufacturer or Colesevelam Hydrochloride supplier.

PharmaCompass also assists you with knowing the Colesevelam Hydrochloride API Price utilized in the formulation of products. Colesevelam Hydrochloride API Price is not always fixed or binding as the Colesevelam Hydrochloride Price is obtained through a variety of data sources. The Colesevelam Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Colesevelam Hydrochloride

Synonyms

Welchol, Colesevelam hcl, 2-(chloromethyl)oxirane;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride, Gt 31-104hb, Unii-p4sg24wi5q, Gt-31104

Cas Number

182815-43-6

About Colesevelam Hydrochloride

An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

Colesevelam Manufacturers

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

Colesevelam Suppliers

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

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

Colesevelam USDMF

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

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

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

Colesevelam Manufacturers | Traders | Suppliers

Colesevelam Manufacturers, Traders, Suppliers 1
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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