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PharmaCompass offers a list of butanol 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 butanol manufacturer or butanol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred butanol manufacturer or butanol supplier.
PharmaCompass also assists you with knowing the butanol API Price utilized in the formulation of products. butanol API Price is not always fixed or binding as the butanol Price is obtained through a variety of data sources. The butanol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A butanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of butanol, including repackagers and relabelers. The FDA regulates butanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. butanol 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 butanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A butanol supplier is an individual or a company that provides butanol active pharmaceutical ingredient (API) or butanol finished formulations upon request. The butanol suppliers may include butanol API manufacturers, exporters, distributors and traders.
click here to find a list of butanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 butanol Drug Master File in Korea (butanol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of butanol. The MFDS reviews the butanol KDMF as part of the drug registration process and uses the information provided in the butanol KDMF to evaluate the safety and efficacy of the drug.
After submitting a butanol 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 butanol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of butanol suppliers with KDMF on PharmaCompass.
butanol 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 butanol 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 butanol GMP manufacturer or butanol GMP API supplier for your needs.
A butanol CoA (Certificate of Analysis) is a formal document that attests to butanol's compliance with butanol specifications and serves as a tool for batch-level quality control.
butanol CoA mostly includes findings from lab analyses of a specific batch. For each butanol 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.
butanol may be tested according to a variety of international standards, such as European Pharmacopoeia (butanol EP), butanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (butanol USP).