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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 |
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21444
Submission : 2008-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36991
Submission : 2022-03-29
Status : Active
Type : II
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm : Village Fatehgarh Chana, Mansa Road, Barnala, Punjab
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0126-Amended
Address of the Firm : R.S No.33 and 34 Mathur Road Periyakalapet, Punducherry India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 46438-0003
Start Marketing Date : 2008-06-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 55679-112
Start Marketing Date : 2006-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Registration Country : India
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Dosage Form : Tablet
Dosage Strength : 342MG
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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Registration Country : Italy
Brand Name : Arfen
Dosage Form : Injectable
Dosage Strength : 400MG
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Brand Name : NEOPROFEN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
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Approval Date : 2006-04-13
Application Number : 21903
Regulatory Info : RX
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Registration Country : France
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Dosage Form : Film Coated Tablet
Dosage Strength : 400MG
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Registration Country : France
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Registration Country : Spain
Brand Name : 20 Envelopes Alogesia 600Mg Powder For Oral Suspension
Dosage Form : Powder For Oral Suspension
Dosage Strength : 600 Mg/Powder for Oral Suspension
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Registration Country : Spain
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Brand Name : 20 Envelopes Dolorac 600Mg Powder For Oral Suspension
Dosage Form : Powder For Oral Suspension
Dosage Strength : 600 Mg/Powder for Oral Suspension
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Registration Country : Spain
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Registration Country : Spain
Brand Name : Algidrin Pediatric 20Mg/Ml 200Ml Oral Suspension
Dosage Form : Oral Suspension
Dosage Strength : 20MG/ML 200ml/Oral Suspension
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Registration Country : Spain
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Dosage Strength : 400MG
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ABOUT THIS PAGE
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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