Synopsis
Synopsis
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CEP/COS
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JDMF
0
KDMF
0
VMF
0
EDQM
0
USP
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JP
0
Others
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South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. Chebi:72305
2. Teduglutide (rdna Origin)
3. Chembl2104987
4. Bdbm50183895
| Molecular Weight | 3752.1 g/mol |
|---|---|
| Molecular Formula | C164H252N44O55S |
| XLogP3 | -15.2 |
| Hydrogen Bond Donor Count | 55 |
| Hydrogen Bond Acceptor Count | 60 |
| Rotatable Bond Count | 126 |
| Exact Mass | 3750.8028943 g/mol |
| Monoisotopic Mass | 3749.7995395 g/mol |
| Topological Polar Surface Area | 1650 Ų |
| Heavy Atom Count | 264 |
| Formal Charge | 0 |
| Complexity | 9030 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 38 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Date of Issue : 2025-09-24
Valid Till : 2028-08-08
Written Confirmation Number : WC-0383
Address of the Firm : Unit-ll, Sy No * Parts of 454,455,457,458 & 459 Chandampet-Village, Shankarampet...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 41524-0009
Start Marketing Date : 2017-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-036
Start Marketing Date : 2024-11-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-106
Start Marketing Date : 2022-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0264
Start Marketing Date : 2021-10-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63557-1031
Start Marketing Date : 2022-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : Available Dossier- US
Registration Country : Italy
Brand Name :
Dosage Form : Lyophilizate
Dosage Strength : 5MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Revestive
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 5 mg
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : GATTEX KIT
Dosage Form : POWDER;SUBCUTANEOUS
Dosage Strength : 5MG/VIAL
Packaging :
Approval Date : 2012-12-21
Application Number : 203441
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 1.25mg
Packaging :
Approval Date : 23/06/2017
Application Number : 20160705000065
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg
Packaging :
Approval Date : 30/08/2012
Application Number : 20110412000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg/5ml
Packaging :
Approval Date : 01/09/2016
Application Number : 65739
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Revestive
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 5MG
Packaging :
Approval Date : 2013-05-28
Application Number : 12787001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : REVESTIVE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 5MG/VIAL
Packaging : 28X5MG VIALS & 28X0.5ML PFS
Approval Date :
Application Number : 2445727
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Revestive
Dosage Form :
Dosage Strength :
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Revestive
Dosage Form :
Dosage Strength :
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info : Available Dossier- US
Registration Country : Italy
Brand Name :
Dosage Form : Lyophilizate
Dosage Strength : 5MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Revestive
Dosage Form : Powder and liquid to the injection fluid, resolution
Dosage Strength : 5 mg
Packaging : Set
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 1.25mg
Packaging :
Approval Date : 23/06/2017
Application Number : 20160705000065
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg
Packaging :
Approval Date : 30/08/2012
Application Number : 20110412000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Revestive
Dosage Form : Solution For Injection
Dosage Strength : 5mg/5ml
Packaging :
Approval Date : 01/09/2016
Application Number : 65739
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Revestive
Dosage Form : Powder And Solvent For Injectable Solution
Dosage Strength : 5MG
Packaging :
Approval Date : 2013-05-28
Application Number : 12787001
Regulatory Info : Authorized
Registration Country : Spain
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : REVESTIVE
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 5MG/VIAL
Packaging : 28X5MG VIALS & 28X0.5ML PFS
Approval Date :
Application Number : 2445727
Regulatory Info : Schedule D
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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PharmaCompass offers a list of Teduglutide 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 Teduglutide manufacturer or Teduglutide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Teduglutide manufacturer or Teduglutide supplier.
PharmaCompass also assists you with knowing the Teduglutide API Price utilized in the formulation of products. Teduglutide API Price is not always fixed or binding as the Teduglutide Price is obtained through a variety of data sources. The Teduglutide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Teduglutide Recombinant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teduglutide Recombinant, including repackagers and relabelers. The FDA regulates Teduglutide Recombinant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teduglutide Recombinant 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 Teduglutide Recombinant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teduglutide Recombinant supplier is an individual or a company that provides Teduglutide Recombinant active pharmaceutical ingredient (API) or Teduglutide Recombinant finished formulations upon request. The Teduglutide Recombinant suppliers may include Teduglutide Recombinant API manufacturers, exporters, distributors and traders.
click here to find a list of Teduglutide Recombinant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teduglutide Recombinant DMF (Drug Master File) is a document detailing the whole manufacturing process of Teduglutide Recombinant active pharmaceutical ingredient (API) in detail. Different forms of Teduglutide Recombinant DMFs exist exist since differing nations have different regulations, such as Teduglutide Recombinant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teduglutide Recombinant DMF submitted to regulatory agencies in the US is known as a USDMF. Teduglutide Recombinant USDMF includes data on Teduglutide Recombinant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teduglutide Recombinant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teduglutide Recombinant suppliers with USDMF on PharmaCompass.
A Teduglutide Recombinant written confirmation (Teduglutide Recombinant WC) is an official document issued by a regulatory agency to a Teduglutide Recombinant manufacturer, verifying that the manufacturing facility of a Teduglutide Recombinant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Teduglutide Recombinant APIs or Teduglutide Recombinant finished pharmaceutical products to another nation, regulatory agencies frequently require a Teduglutide Recombinant WC (written confirmation) as part of the regulatory process.
click here to find a list of Teduglutide Recombinant 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 Teduglutide Recombinant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Teduglutide Recombinant 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 Teduglutide Recombinant 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 Teduglutide Recombinant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Teduglutide Recombinant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Teduglutide Recombinant suppliers with NDC on PharmaCompass.
Teduglutide Recombinant 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 Teduglutide Recombinant 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 Teduglutide Recombinant GMP manufacturer or Teduglutide Recombinant GMP API supplier for your needs.
A Teduglutide Recombinant CoA (Certificate of Analysis) is a formal document that attests to Teduglutide Recombinant's compliance with Teduglutide Recombinant specifications and serves as a tool for batch-level quality control.
Teduglutide Recombinant CoA mostly includes findings from lab analyses of a specific batch. For each Teduglutide Recombinant 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.
Teduglutide Recombinant may be tested according to a variety of international standards, such as European Pharmacopoeia (Teduglutide Recombinant EP), Teduglutide Recombinant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teduglutide Recombinant USP).
