Synopsis
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JP
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1. Hexadecanoic Acid Octadecyl Ester
2. Octadecyl Hexadecanoate
3. Octadecyl Palmitate
4. Palmitic Acid Octadecyl Ester
5. Stearyl Palmitate
1. Stearyl Palmitate
2. Octadecyl Palmitate
3. Octadecyl Hexadecanoate
4. 2598-99-4
5. Hexadecanoic Acid, Octadecyl Ester
6. Palmitic Acid Stearyl Ester
7. 100231-75-2
8. 8006-54-0
9. Octadecanyl Hexadecanoate
10. Palmitic Acid, Octadecyl Ester
11. 214w90o2xz
12. We(18:0/16:0)
13. Einecs 220-000-6
14. Unii-214w90o2xz
15. Wool Grease
16. Ai3-30713
17. Wool Wax
18. Einecs 309-376-3
19. Wool Wax;wool Grease
20. Stearyl Palmitate, >=99%
21. Schembl33919
22. Dtxsid0026048
23. Stearyl Palmitate [inci]
24. Chebi:84066
25. Caa59899
26. Palmitic Acid, Stearyl Ester
27. Lmfa07010049
28. Zinc60050365
29. Akos028115046
30. Ccg-269767
31. Db-046811
32. Ft-0634387
33. J-016213
34. Q27157447
Molecular Weight | 508.9 g/mol |
---|---|
Molecular Formula | C34H68O2 |
XLogP3 | 16.3 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 32 |
Exact Mass | 508.52193141 g/mol |
Monoisotopic Mass | 508.52193141 g/mol |
Topological Polar Surface Area | 26.3 Ų |
Heavy Atom Count | 36 |
Formal Charge | 0 |
Complexity | 406 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Since certain individuals are allergic to this substance, it should not be used in ointments intended for use by sensitive persons.
Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1250
1= PRACTICALLY NONTOXIC: PROBABLE ORAL LETHAL DOSE (HUMAN) ABOVE 15 G/KG, MORE THAN 1 QT FOR 70 KG PERSON (150 LB).
Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-152
Used as a skin protectant, and to relieve dryness and irritation of the skin,. Helps prevent and treat diaper dermatitis.
Lanolin treats cracked, dry, irritated skin and minor burns. It prevents and treats sore nipples during breastfeeding,. Protects chafed skin or minor skin irritations due to various causes,.
Lanolin is an emollient. Emollients soften the skin by forming an occlusive oil film on the stratum corneum layer of the epithelium, thus decreasing the transepidermal water loss.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38906
Submission : 2023-12-27
Status : Active
Type : IV
Certificate Number : CEP 2024-036 - Rev 00
Issue Date : 2024-05-30
Type : TSE
Substance Number : 134
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12789
Submission : 1997-12-17
Status : Inactive
Type : IV
Certificate Number : R1-CEP 2002-124 - Rev 01
Issue Date : 2009-05-18
Type : TSE
Substance Number : 134
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2014-368 - Rev 01
Issue Date : 2024-08-26
Type : TSE
Substance Number : 134
Status : Valid
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Certificate Number : R0-CEP 2023-009 - Rev 00
Issue Date : 2023-06-20
Type : TSE
Substance Number : 134
Status : Valid
Certificate Number : R1-CEP 2001-247 - Rev 01
Issue Date : 2015-10-20
Type : TSE
Substance Number : 134
Status : Valid
Certificate Number : R0-CEP 2007-334 - Rev 00
Issue Date : 2008-06-20
Type : TSE
Substance Number : 134
Status : Expired
Certificate Number : R0-CEP 2016-030 - Rev 00
Issue Date : 2016-04-01
Type : TSE
Substance Number : 134
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38906
Submission : 2023-12-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12789
Submission : 1997-12-17
Status : Inactive
Type : IV
Certificate Number : CEP 2024-036 - Rev 00
Status : Valid
Issue Date : 2024-05-30
Type : TSE
Substance Number : 134
Wool Fat, (Product Codes: LA04918, LA01439, LA00...
Certificate Number : R1-CEP 2001-247 - Rev 01
Status : Valid
Issue Date : 2015-10-20
Type : TSE
Substance Number : 134
Certificate Number : R0-CEP 2016-030 - Rev 00
Status : Expired
Issue Date : 2016-04-01
Type : TSE
Substance Number : 134
Certificate Number : R1-CEP 2002-124 - Rev 01
Status : Valid
Issue Date : 2009-05-18
Type : TSE
Substance Number : 134
Certificate Number : R1-CEP 2003-124 - Rev 01
Status : Valid
Issue Date : 2013-08-21
Type : TSE
Substance Number : 134
Certificate Number : R0-CEP 2007-334 - Rev 00
Status : Expired
Issue Date : 2008-06-20
Type : TSE
Substance Number : 134
Wool Fat, (Product Codes: LA08944, LA08625, LA08...
Certificate Number : R0-CEP 2001-380 - Rev 01
Status : Expired
Issue Date : 2005-03-22
Type : TSE
Substance Number : 134
Certificate Number : R0-CEP 2023-009 - Rev 00
Status : Valid
Issue Date : 2023-06-20
Type : TSE
Substance Number : 134
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Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2014-368 - Rev 01
Status : Valid
Issue Date : 2024-08-26
Type : TSE
Substance Number : 134
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : OTC
Registration Country : Canada
Brand Name : SYSTANE OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 3%
Packaging : 3.5G
Approval Date :
Application Number : 2444062
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : UDDER BUDDER ONT
Dosage Form : OINTMENT
Dosage Strength : 5%/%
Packaging : 200G/400G/2KG
Approval Date :
Application Number : 493600
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : LANOVET ONT
Dosage Form : OINTMENT
Dosage Strength : 50MG/G
Packaging : 200/400G/2KG
Approval Date :
Application Number : 509043
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : BARRICADE
Dosage Form : SOLUTION
Dosage Strength : 2%
Packaging : 18.9/56.8L PAIL/208L DRUM/1150L TOTE
Approval Date :
Application Number : 2282577
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info :
Registration Country : Portugal
Honey; Lanolin; Zinc Oxide; Vitamin C
Brand Name : L-Mesitran
Dosage Form : Ointment
Dosage Strength : 48%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : Portugal
Honey; Lanolin; Propylene Glycol; Vitamin C
Brand Name : L-Mesitran
Dosage Form : Gel
Dosage Strength : 40%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info : OTC
Registration Country : Canada
Brand Name : HUILE DE BAIN THERAPEUTIQUE
Dosage Form : SOLUTION
Dosage Strength : 3%
Packaging : 480
Approval Date :
Application Number : 1939068
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ointment
Dosage Strength : 100%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : OTC
Registration Country : Canada
Brand Name : HOOF CARE
Dosage Form : OINTMENT
Dosage Strength : 90MG/ML
Packaging : 946ML/3.8L
Approval Date :
Application Number : 2441179
Regulatory Info : OTC
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : OTC
Registration Country : Canada
Brand Name : SYSTANE OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 3%
Packaging : 3.5G
Approval Date :
Application Number : 2444062
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : UDDER BUDDER ONT
Dosage Form : OINTMENT
Dosage Strength : 5%/%
Packaging : 200G/400G/2KG
Approval Date :
Application Number : 493600
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : LANOVET ONT
Dosage Form : OINTMENT
Dosage Strength : 50MG/G
Packaging : 200/400G/2KG
Approval Date :
Application Number : 509043
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : BARRICADE
Dosage Form : SOLUTION
Dosage Strength : 2%
Packaging : 18.9/56.8L PAIL/208L DRUM/1150L TOTE
Approval Date :
Application Number : 2282577
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : HUILE DE BAIN THERAPEUTIQUE
Dosage Form : SOLUTION
Dosage Strength : 3%
Packaging : 480
Approval Date :
Application Number : 1939068
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : HOOF CARE
Dosage Form : OINTMENT
Dosage Strength : 90MG/ML
Packaging : 946ML/3.8L
Approval Date :
Application Number : 2441179
Regulatory Info : OTC
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Portugal
Honey; Lanolin; Zinc Oxide; Vitamin C
Brand Name : L-Mesitran
Dosage Form : Ointment
Dosage Strength : 48%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Packaging :
Regulatory Info :
Honey; Lanolin; Zinc Oxide; Vitamin C
Dosage : Ointment
Dosage Strength : 48%
Brand Name : L-Mesitran
Approval Date :
Application Number :
Registration Country : Portugal
Regulatory Info :
Registration Country : Portugal
Honey; Lanolin; Propylene Glycol; Vitamin C
Brand Name : L-Mesitran
Dosage Form : Gel
Dosage Strength : 40%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Packaging :
Regulatory Info :
Honey; Lanolin; Propylene Glycol; Vitamin C
Dosage : Gel
Dosage Strength : 40%
Brand Name : L-Mesitran
Approval Date :
Application Number :
Registration Country : Portugal
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ointment
Dosage Strength : 100%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Ointment
Dosage Strength : 100%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Market Place
ABOUT THIS PAGE
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PharmaCompass offers a list of Lanolin 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 Lanolin manufacturer or Lanolin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lanolin manufacturer or Lanolin supplier.
PharmaCompass also assists you with knowing the Lanolin API Price utilized in the formulation of products. Lanolin API Price is not always fixed or binding as the Lanolin Price is obtained through a variety of data sources. The Lanolin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lanolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanolin, including repackagers and relabelers. The FDA regulates Lanolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanolin 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 Lanolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanolin supplier is an individual or a company that provides Lanolin active pharmaceutical ingredient (API) or Lanolin finished formulations upon request. The Lanolin suppliers may include Lanolin API manufacturers, exporters, distributors and traders.
click here to find a list of Lanolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanolin active pharmaceutical ingredient (API) in detail. Different forms of Lanolin DMFs exist exist since differing nations have different regulations, such as Lanolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanolin DMF submitted to regulatory agencies in the US is known as a USDMF. Lanolin USDMF includes data on Lanolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanolin suppliers with USDMF on PharmaCompass.
A Lanolin CEP of the European Pharmacopoeia monograph is often referred to as a Lanolin Certificate of Suitability (COS). The purpose of a Lanolin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lanolin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lanolin to their clients by showing that a Lanolin CEP has been issued for it. The manufacturer submits a Lanolin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lanolin CEP holder for the record. Additionally, the data presented in the Lanolin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lanolin DMF.
A Lanolin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lanolin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Lanolin suppliers with CEP (COS) on PharmaCompass.
Lanolin 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 Lanolin 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 Lanolin GMP manufacturer or Lanolin GMP API supplier for your needs.
A Lanolin CoA (Certificate of Analysis) is a formal document that attests to Lanolin's compliance with Lanolin specifications and serves as a tool for batch-level quality control.
Lanolin CoA mostly includes findings from lab analyses of a specific batch. For each Lanolin 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.
Lanolin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanolin EP), Lanolin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanolin USP).