API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
EU WC
0
Listed Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
61
PharmaCompass offers a list of Sorbitol API 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 Sorbitol API manufacturer or Sorbitol API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sorbitol API manufacturer or Sorbitol API supplier.
PharmaCompass also assists you with knowing the Sorbitol API API Price utilized in the formulation of products. Sorbitol API API Price is not always fixed or binding as the Sorbitol API Price is obtained through a variety of data sources. The Sorbitol API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sorbitol API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorbitol API, including repackagers and relabelers. The FDA regulates Sorbitol API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorbitol API 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 Sorbitol API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sorbitol API supplier is an individual or a company that provides Sorbitol API active pharmaceutical ingredient (API) or Sorbitol API finished formulations upon request. The Sorbitol API suppliers may include Sorbitol API API manufacturers, exporters, distributors and traders.
click here to find a list of Sorbitol API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sorbitol API DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorbitol API active pharmaceutical ingredient (API) in detail. Different forms of Sorbitol API DMFs exist exist since differing nations have different regulations, such as Sorbitol API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorbitol API DMF submitted to regulatory agencies in the US is known as a USDMF. Sorbitol API USDMF includes data on Sorbitol API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorbitol API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sorbitol API 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 Sorbitol API Drug Master File in Japan (Sorbitol API JDMF) empowers Sorbitol API 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 Sorbitol API JDMF during the approval evaluation for pharmaceutical products. At the time of Sorbitol API 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 Sorbitol API suppliers with JDMF on PharmaCompass.
Sorbitol API 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 Sorbitol API 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 Sorbitol API GMP manufacturer or Sorbitol API GMP API supplier for your needs.
A Sorbitol API CoA (Certificate of Analysis) is a formal document that attests to Sorbitol API's compliance with Sorbitol API specifications and serves as a tool for batch-level quality control.
Sorbitol API CoA mostly includes findings from lab analyses of a specific batch. For each Sorbitol API 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.
Sorbitol API may be tested according to a variety of international standards, such as European Pharmacopoeia (Sorbitol API EP), Sorbitol API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sorbitol API USP).