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PharmaCompass offers a list of Isosorbide 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 Isosorbide manufacturer or Isosorbide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide manufacturer or Isosorbide supplier.
PharmaCompass also assists you with knowing the Isosorbide API Price utilized in the formulation of products. Isosorbide API Price is not always fixed or binding as the Isosorbide Price is obtained through a variety of data sources. The Isosorbide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ISMOTIC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ISMOTIC, including repackagers and relabelers. The FDA regulates ISMOTIC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ISMOTIC 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 ISMOTIC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ISMOTIC supplier is an individual or a company that provides ISMOTIC active pharmaceutical ingredient (API) or ISMOTIC finished formulations upon request. The ISMOTIC suppliers may include ISMOTIC API manufacturers, exporters, distributors and traders.
click here to find a list of ISMOTIC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ISMOTIC DMF (Drug Master File) is a document detailing the whole manufacturing process of ISMOTIC active pharmaceutical ingredient (API) in detail. Different forms of ISMOTIC DMFs exist exist since differing nations have different regulations, such as ISMOTIC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ISMOTIC DMF submitted to regulatory agencies in the US is known as a USDMF. ISMOTIC USDMF includes data on ISMOTIC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ISMOTIC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ISMOTIC 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 ISMOTIC Drug Master File in Japan (ISMOTIC JDMF) empowers ISMOTIC 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 ISMOTIC JDMF during the approval evaluation for pharmaceutical products. At the time of ISMOTIC 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 ISMOTIC suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ISMOTIC Drug Master File in Korea (ISMOTIC KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ISMOTIC. The MFDS reviews the ISMOTIC KDMF as part of the drug registration process and uses the information provided in the ISMOTIC KDMF to evaluate the safety and efficacy of the drug.
After submitting a ISMOTIC KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their ISMOTIC API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ISMOTIC suppliers with KDMF on PharmaCompass.
ISMOTIC 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 ISMOTIC 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 ISMOTIC GMP manufacturer or ISMOTIC GMP API supplier for your needs.
A ISMOTIC CoA (Certificate of Analysis) is a formal document that attests to ISMOTIC's compliance with ISMOTIC specifications and serves as a tool for batch-level quality control.
ISMOTIC CoA mostly includes findings from lab analyses of a specific batch. For each ISMOTIC 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.
ISMOTIC may be tested according to a variety of international standards, such as European Pharmacopoeia (ISMOTIC EP), ISMOTIC JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ISMOTIC USP).
