API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
63
PharmaCompass offers a list of Isopropyl Alcohol 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 Isopropyl Alcohol manufacturer or Isopropyl Alcohol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isopropyl Alcohol manufacturer or Isopropyl Alcohol supplier.
PharmaCompass also assists you with knowing the Isopropyl Alcohol API Price utilized in the formulation of products. Isopropyl Alcohol API Price is not always fixed or binding as the Isopropyl Alcohol Price is obtained through a variety of data sources. The Isopropyl Alcohol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isopropanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isopropanol, including repackagers and relabelers. The FDA regulates Isopropanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isopropanol 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 Isopropanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isopropanol supplier is an individual or a company that provides Isopropanol active pharmaceutical ingredient (API) or Isopropanol finished formulations upon request. The Isopropanol suppliers may include Isopropanol API manufacturers, exporters, distributors and traders.
click here to find a list of Isopropanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isopropanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Isopropanol active pharmaceutical ingredient (API) in detail. Different forms of Isopropanol DMFs exist exist since differing nations have different regulations, such as Isopropanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isopropanol DMF submitted to regulatory agencies in the US is known as a USDMF. Isopropanol USDMF includes data on Isopropanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isopropanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isopropanol suppliers with USDMF 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 Isopropanol Drug Master File in Korea (Isopropanol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isopropanol. The MFDS reviews the Isopropanol KDMF as part of the drug registration process and uses the information provided in the Isopropanol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isopropanol 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 Isopropanol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isopropanol suppliers with KDMF on PharmaCompass.
A Isopropanol CEP of the European Pharmacopoeia monograph is often referred to as a Isopropanol Certificate of Suitability (COS). The purpose of a Isopropanol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isopropanol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isopropanol to their clients by showing that a Isopropanol CEP has been issued for it. The manufacturer submits a Isopropanol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isopropanol CEP holder for the record. Additionally, the data presented in the Isopropanol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isopropanol DMF.
A Isopropanol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isopropanol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Isopropanol suppliers with CEP (COS) on PharmaCompass.
Isopropanol 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 Isopropanol 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 Isopropanol GMP manufacturer or Isopropanol GMP API supplier for your needs.
A Isopropanol CoA (Certificate of Analysis) is a formal document that attests to Isopropanol's compliance with Isopropanol specifications and serves as a tool for batch-level quality control.
Isopropanol CoA mostly includes findings from lab analyses of a specific batch. For each Isopropanol 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.
Isopropanol may be tested according to a variety of international standards, such as European Pharmacopoeia (Isopropanol EP), Isopropanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isopropanol USP).