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JDMF
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1. Ibuprofen Lysine
2. 57469-76-8
3. Ibuprofen Dl-lysine
4. Ibuprofen D,l-lysinate
5. 079x7dl13m
6. (rs)-2-(4-(2-methylpropyl)phenyl)propanoic Acid D,l-lysine Salt
7. 2,6-diaminohexanoic Acid Compound With 2-(4-isobutylphenyl)propanoic Acid (1:1)
8. (rs)-2-[4-(2-methylpropyl)phenyl]propanoic Acid D,l-lysine Salt
9. (2s)-2,6-diaminohexanoic Acid;2-[4-(2-methylpropyl)phenyl]propanoic Acid
10. Neoprofen;ibuprofen-lys
11. Starbld0004237
12. Schembl44616
13. Unii-079x7dl13m
14. Dtxsid50432054
15. Bcp27681
16. Akos015963349
17. Ac-19865
18. Ac-32764
19. Ft-0670261
20. Ft-0670262
21. Lysine, Mono(alpha-methyl-4-(2-methylpropyl)benzeneacetate)
22. Dl-lysine, Mono(alpha-methyl-4-(2-methylpropyl)benzeneacetate)
23. Lysine, Alpha-methyl-4-(2-methylpropyl)benzeneacetate (1:1)
24. Dl-lysine, Mono(.alpha.-methyl-4-(2-methylpropyl)benzeneacetate)
25. Lysine, .alpha.-methyl-4-(2-methylpropyl)benzeneacetate (1:1)
26. Lysine, Mono(.alpha.-methyl-4-(2-methylpropyl)benzeneacetate)
27. Benzeneacetic Acid, .alpha.-methyl-4-(2-methylpropyl)-, Compd. With Lysine (1:1)
28. Benzeneacetic Acid, Alpha-methyl-4-(2-methylpropyl)-, Compd. With Lysine (1:1)
| Molecular Weight | 352.5 g/mol |
|---|---|
| Molecular Formula | C19H32N2O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 9 |
| Exact Mass | 352.23620751 g/mol |
| Monoisotopic Mass | 352.23620751 g/mol |
| Topological Polar Surface Area | 127 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 309 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |

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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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RLD : Yes
TE Code : AP
Brand Name : NEOPROFEN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date : 2006-04-13
Application Number : 21903
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP

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RLD : No
TE Code : AP
Brand Name : IBUPROFEN LYSINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Approval Date : 2016-03-30
Application Number : 202402
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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Regulatory Info : Generic
Registration Country : Italy
Brand Name : Jointral
Dosage Form : Gel
Dosage Strength : 10%
Packaging : 50 G
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Italy

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Regulatory Info : Generic
Registration Country : Italy
Brand Name : Arfen
Dosage Form : Injectable
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Italy

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Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Ibuprofen (Lysine) Mylan
Dosage Form : Soft Capsule
Dosage Strength : 200MG
Packaging :
Approval Date : 2020-01-08
Application Number : 84699
Regulatory Info : Cancelled
Registration Country : Spain

Regulatory Info : Authorized
Registration Country : Spain
Ibuprofene Lysine; Chlorphenamine Maleate; Phenylephhrine Hydrochloride
Brand Name : Couldina With Ibuprofen Effervescent Tablets
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date : 2017-03-01
Application Number : 81807
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Suspensed
Registration Country : Spain
Brand Name : Pediatric Pain
Dosage Form : Oral Suspension
Dosage Strength : 20MG
Packaging :
Approval Date : 2014-06-30
Application Number : 78862
Regulatory Info : Suspensed
Registration Country : Spain

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Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Alogesia
Dosage Form : Oral Suspension
Dosage Strength : 600MG
Packaging :
Approval Date : 2002-02-22
Application Number : 64583
Regulatory Info : Cancelled
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Algidrin Pediatric
Dosage Form : Oral Suspension
Dosage Strength : 40MG
Packaging :
Approval Date : 2019-11-14
Application Number : 84644
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Genovedo
Dosage Form : Powder For Oral Solution
Dosage Strength : 400MG
Packaging :
Approval Date : 2017-02-21
Application Number : 81783
Regulatory Info : Cancelled
Registration Country : Spain

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Regulatory Info : Suspensed
Registration Country : Spain
Brand Name : Doctril Strongly
Dosage Form : Film Coated Tablet
Dosage Strength : 400MG
Packaging :
Approval Date : 1998-10-01
Application Number : 62258
Regulatory Info : Suspensed
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Algidrin Children
Dosage Form : Powder For Oral Suspension
Dosage Strength : 200MG
Packaging :
Approval Date : 2005-06-06
Application Number : 66868
Regulatory Info : Authorized
Registration Country : Spain

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory Info :
Registration Country : India
Brand Name : Ibuprofen Lysine
Dosage Form : Tablet
Dosage Strength : 342MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 342MG
Brand Name : Ibuprofen Lysine
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Ibuprofen Lysine
Dosage Form : Tablet
Dosage Strength : 684MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 684MG
Brand Name : Ibuprofen Lysine
Approval Date :
Application Number :
Registration Country : India
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Regulatory Info :
Registration Country : India
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 200MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 400MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 600MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France

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Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 400MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France

Regulatory Info :
Registration Country :
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 200MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country :

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Product Web Link
Virtual Booth
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Regulatory Info :
Registration Country :
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

Portfolio PDF
Product Web Link
Virtual Booth
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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 400MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country :

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Product Web Link
Virtual Booth
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Regulatory Info :
Registration Country :
Brand Name : Flamibul
Dosage Form : Tablet
Dosage Strength : 600MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

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Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 600MG
Brand Name : Flamibul
Approval Date :
Application Number :
Registration Country :

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Patents & EXCLUSIVITIES
ANALYTICAL
ABOUT THIS PAGE
26
PharmaCompass offers a list of Ibuprofen Lysinate 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 Ibuprofen Lysinate manufacturer or Ibuprofen Lysinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ibuprofen Lysinate manufacturer or Ibuprofen Lysinate supplier.
PharmaCompass also assists you with knowing the Ibuprofen Lysinate API Price utilized in the formulation of products. Ibuprofen Lysinate API Price is not always fixed or binding as the Ibuprofen Lysinate Price is obtained through a variety of data sources. The Ibuprofen Lysinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ibuprofen Lysinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibuprofen Lysinate, including repackagers and relabelers. The FDA regulates Ibuprofen Lysinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibuprofen Lysinate 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 Ibuprofen Lysinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibuprofen Lysinate supplier is an individual or a company that provides Ibuprofen Lysinate active pharmaceutical ingredient (API) or Ibuprofen Lysinate finished formulations upon request. The Ibuprofen Lysinate suppliers may include Ibuprofen Lysinate API manufacturers, exporters, distributors and traders.
click here to find a list of Ibuprofen Lysinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibuprofen Lysinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibuprofen Lysinate active pharmaceutical ingredient (API) in detail. Different forms of Ibuprofen Lysinate DMFs exist exist since differing nations have different regulations, such as Ibuprofen Lysinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibuprofen Lysinate DMF submitted to regulatory agencies in the US is known as a USDMF. Ibuprofen Lysinate USDMF includes data on Ibuprofen Lysinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibuprofen Lysinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibuprofen Lysinate suppliers with USDMF on PharmaCompass.
A Ibuprofen Lysinate written confirmation (Ibuprofen Lysinate WC) is an official document issued by a regulatory agency to a Ibuprofen Lysinate manufacturer, verifying that the manufacturing facility of a Ibuprofen Lysinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ibuprofen Lysinate APIs or Ibuprofen Lysinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ibuprofen Lysinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Ibuprofen Lysinate 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 Ibuprofen Lysinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ibuprofen Lysinate 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 Ibuprofen Lysinate 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 Ibuprofen Lysinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ibuprofen Lysinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ibuprofen Lysinate suppliers with NDC on PharmaCompass.
Ibuprofen Lysinate 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 Ibuprofen Lysinate 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 Ibuprofen Lysinate GMP manufacturer or Ibuprofen Lysinate GMP API supplier for your needs.
A Ibuprofen Lysinate CoA (Certificate of Analysis) is a formal document that attests to Ibuprofen Lysinate's compliance with Ibuprofen Lysinate specifications and serves as a tool for batch-level quality control.
Ibuprofen Lysinate CoA mostly includes findings from lab analyses of a specific batch. For each Ibuprofen Lysinate 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.
Ibuprofen Lysinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ibuprofen Lysinate EP), Ibuprofen Lysinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ibuprofen Lysinate USP).
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