Synopsis
Synopsis
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CEP/COS
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EU WC
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KDMF
0
VMF
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EDQM
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USP
0
JP
0
Others
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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FDF
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1. 2,5,8,11,14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80-heptacosaoxadooctacontan-82-ol
2. Chebi:44817
3. 2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol
4. Q27120584
Molecular Weight | 1221.5 g/mol |
---|---|
Molecular Formula | C55H112O28 |
XLogP3 | -4.4 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 28 |
Rotatable Bond Count | 80 |
Exact Mass | 1220.73401291 g/mol |
Monoisotopic Mass | 1220.73401291 g/mol |
Topological Polar Surface Area | 269 Ų |
Heavy Atom Count | 83 |
Formal Charge | 0 |
Complexity | 1070 |
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 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21153
Submission : 2007-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35552
Submission : 2021-03-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22570
Submission : 2009-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27603
Submission : 2013-10-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28678
Submission : 2014-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29335
Submission : 2015-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29524
Submission : 2015-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35636
Submission : 2021-03-02
Status : Active
Type : II
NDC Package Code : 57449-011
Start Marketing Date : 2023-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 218MF20001
Registrant's Address : 2211 H. H. Dow Way, Midland MI 48674, United States
Initial Date of Registration : 2006-02-23
Latest Date of Registration :
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Dosage Form : Gel
Grade : Oral, Topical
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Patents & EXCLUSIVITIES
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Lauromacrogol 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 Lauromacrogol manufacturer or Lauromacrogol supplier for your needs.
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PharmaCompass also assists you with knowing the Lauromacrogol API Price utilized in the formulation of products. Lauromacrogol API Price is not always fixed or binding as the Lauromacrogol Price is obtained through a variety of data sources. The Lauromacrogol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1000, PEG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1000, PEG, including repackagers and relabelers. The FDA regulates 1000, PEG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1000, PEG 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 1000, PEG manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1000, PEG supplier is an individual or a company that provides 1000, PEG active pharmaceutical ingredient (API) or 1000, PEG finished formulations upon request. The 1000, PEG suppliers may include 1000, PEG API manufacturers, exporters, distributors and traders.
click here to find a list of 1000, PEG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1000, PEG DMF (Drug Master File) is a document detailing the whole manufacturing process of 1000, PEG active pharmaceutical ingredient (API) in detail. Different forms of 1000, PEG DMFs exist exist since differing nations have different regulations, such as 1000, PEG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1000, PEG DMF submitted to regulatory agencies in the US is known as a USDMF. 1000, PEG USDMF includes data on 1000, PEG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1000, PEG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1000, PEG suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The 1000, PEG Drug Master File in Japan (1000, PEG JDMF) empowers 1000, PEG API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the 1000, PEG JDMF during the approval evaluation for pharmaceutical products. At the time of 1000, PEG JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of 1000, PEG suppliers with JDMF 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 1000, PEG as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1000, PEG 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 1000, PEG 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 1000, PEG and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1000, PEG NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 1000, PEG suppliers with NDC on PharmaCompass.
1000, PEG 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 1000, PEG 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 1000, PEG GMP manufacturer or 1000, PEG GMP API supplier for your needs.
A 1000, PEG CoA (Certificate of Analysis) is a formal document that attests to 1000, PEG's compliance with 1000, PEG specifications and serves as a tool for batch-level quality control.
1000, PEG CoA mostly includes findings from lab analyses of a specific batch. For each 1000, PEG 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.
1000, PEG may be tested according to a variety of international standards, such as European Pharmacopoeia (1000, PEG EP), 1000, PEG JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1000, PEG USP).