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1. Ac-681
2. Akos015961943
Molecular Weight | 499.1 g/mol |
---|---|
Molecular Formula | C23H35ClN4O4S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 6 |
Exact Mass | 498.2067545 g/mol |
Monoisotopic Mass | 498.2067545 g/mol |
Topological Polar Surface Area | 87 Ų |
Heavy Atom Count | 33 |
Formal Charge | 0 |
Complexity | 615 |
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 | 4 |
ABOUT THIS PAGE
A Perospirone Hydrochloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perospirone Hydrochloride Hydrate, including repackagers and relabelers. The FDA regulates Perospirone Hydrochloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate supplier is an individual or a company that provides Perospirone Hydrochloride Hydrate active pharmaceutical ingredient (API) or Perospirone Hydrochloride Hydrate finished formulations upon request. The Perospirone Hydrochloride Hydrate suppliers may include Perospirone Hydrochloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Perospirone Hydrochloride Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Perospirone Hydrochloride Hydrate Drug Master File in Japan (Perospirone Hydrochloride Hydrate JDMF) empowers Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate suppliers with JDMF on PharmaCompass.
Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate 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 Perospirone Hydrochloride Hydrate GMP manufacturer or Perospirone Hydrochloride Hydrate GMP API supplier for your needs.
A Perospirone Hydrochloride Hydrate CoA (Certificate of Analysis) is a formal document that attests to Perospirone Hydrochloride Hydrate's compliance with Perospirone Hydrochloride Hydrate specifications and serves as a tool for batch-level quality control.
Perospirone Hydrochloride Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Perospirone Hydrochloride Hydrate 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.
Perospirone Hydrochloride Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Perospirone Hydrochloride Hydrate EP), Perospirone Hydrochloride Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perospirone Hydrochloride Hydrate USP).
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