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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 D00137 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D00137, including repackagers and relabelers. The FDA regulates D00137 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D00137 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 D00137 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A D00137 supplier is an individual or a company that provides D00137 active pharmaceutical ingredient (API) or D00137 finished formulations upon request. The D00137 suppliers may include D00137 API manufacturers, exporters, distributors and traders.
click here to find a list of D00137 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D00137 DMF (Drug Master File) is a document detailing the whole manufacturing process of D00137 active pharmaceutical ingredient (API) in detail. Different forms of D00137 DMFs exist exist since differing nations have different regulations, such as D00137 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D00137 DMF submitted to regulatory agencies in the US is known as a USDMF. D00137 USDMF includes data on D00137's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D00137 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D00137 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 D00137 Drug Master File in Korea (D00137 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of D00137. The MFDS reviews the D00137 KDMF as part of the drug registration process and uses the information provided in the D00137 KDMF to evaluate the safety and efficacy of the drug.
After submitting a D00137 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 D00137 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of D00137 suppliers with KDMF on PharmaCompass.
A D00137 CEP of the European Pharmacopoeia monograph is often referred to as a D00137 Certificate of Suitability (COS). The purpose of a D00137 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of D00137 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of D00137 to their clients by showing that a D00137 CEP has been issued for it. The manufacturer submits a D00137 CEP (COS) as part of the market authorization procedure, and it takes on the role of a D00137 CEP holder for the record. Additionally, the data presented in the D00137 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the D00137 DMF.
A D00137 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. D00137 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 D00137 suppliers with CEP (COS) on PharmaCompass.
D00137 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 D00137 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 D00137 GMP manufacturer or D00137 GMP API supplier for your needs.
A D00137 CoA (Certificate of Analysis) is a formal document that attests to D00137's compliance with D00137 specifications and serves as a tool for batch-level quality control.
D00137 CoA mostly includes findings from lab analyses of a specific batch. For each D00137 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.
D00137 may be tested according to a variety of international standards, such as European Pharmacopoeia (D00137 EP), D00137 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (D00137 USP).
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