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1. Db11573
2. Q27280046
Molecular Weight | 192.47 g/mol |
---|---|
Molecular Formula | Al2ClH7O6 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 0 |
Exact Mass | 191.956192 g/mol |
Monoisotopic Mass | 191.956192 g/mol |
Topological Polar Surface Area | 6 Ų |
Heavy Atom Count | 9 |
Formal Charge | 0 |
Complexity | 0 |
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 | 9 |
Indicated for use as an antiperspirant.
Aluminum chlorohydrate serves to reduce excessive sweating by directly blocking the sweat ducts.
Absorption
Penetration of aluminum chlorohydrate following dermal application is minimal, with the rate being around 0.01% and up to 0.06% in pre-damaged skin. In a preliminary study, dermally applied aluminium chlorohydrate displayed 0.012% of the applied aluminium being absorbed through the skin, which accounts for 4 mcg of aluminum following a single dermal application. This is about 2.5% of the aluminium typically absorbed by the gut from food over the same time period.
Route of Elimination
No pharmacokinetic information available.
Volume of Distribution
No pharmacokinetic information available.
Clearance
No pharmacokinetic information available.
No pharmacokinetic information available.
No pharmacokinetic information available.
Aluminum salts plug eccrine sweat pores and forms aggregates with swear proteins that bind to the wall of the sweat duct and form a tenuous membrane.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26548
Submission : 2012-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1035
Submission : 1967-02-16
Status : Inactive
Type : II
Registration Number : 217MF10700
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : --
Date of Issue : 2022-05-20
Valid Till : 2022-09-11
Written Confirmation Number : WC-0452A4
Address of the Firm :
Dried Aluminium hydroxychloride Gel Magnesium Hydroxide IH
Date of Issue : 2022-05-20
Valid Till : 2022-09-11
Written Confirmation Number : WC-0452A4
Address of the Firm : Block No.3 of Plot No. 1296, 1297/08, Ward No. 03, Mouza- Waddhamna, Amravati Ro...
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ABOUT THIS PAGE
A Aluminium Chlorohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aluminium Chlorohydrate, including repackagers and relabelers. The FDA regulates Aluminium Chlorohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aluminium Chlorohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Aluminium Chlorohydrate supplier is an individual or a company that provides Aluminium Chlorohydrate active pharmaceutical ingredient (API) or Aluminium Chlorohydrate finished formulations upon request. The Aluminium Chlorohydrate suppliers may include Aluminium Chlorohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Aluminium Chlorohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aluminium Chlorohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Aluminium Chlorohydrate active pharmaceutical ingredient (API) in detail. Different forms of Aluminium Chlorohydrate DMFs exist exist since differing nations have different regulations, such as Aluminium Chlorohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aluminium Chlorohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Aluminium Chlorohydrate USDMF includes data on Aluminium Chlorohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aluminium Chlorohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aluminium Chlorohydrate 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 Aluminium Chlorohydrate Drug Master File in Japan (Aluminium Chlorohydrate JDMF) empowers Aluminium Chlorohydrate 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 Aluminium Chlorohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Aluminium Chlorohydrate 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 Aluminium Chlorohydrate suppliers with JDMF on PharmaCompass.
A Aluminium Chlorohydrate written confirmation (Aluminium Chlorohydrate WC) is an official document issued by a regulatory agency to a Aluminium Chlorohydrate manufacturer, verifying that the manufacturing facility of a Aluminium Chlorohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aluminium Chlorohydrate APIs or Aluminium Chlorohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Aluminium Chlorohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Aluminium Chlorohydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Aluminium Chlorohydrate 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 Aluminium Chlorohydrate 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 Aluminium Chlorohydrate GMP manufacturer or Aluminium Chlorohydrate GMP API supplier for your needs.
A Aluminium Chlorohydrate CoA (Certificate of Analysis) is a formal document that attests to Aluminium Chlorohydrate's compliance with Aluminium Chlorohydrate specifications and serves as a tool for batch-level quality control.
Aluminium Chlorohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Aluminium Chlorohydrate 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.
Aluminium Chlorohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Aluminium Chlorohydrate EP), Aluminium Chlorohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aluminium Chlorohydrate USP).
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