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PharmaCompass offers a list of Tromethamine 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 Tromethamine API manufacturer or Tromethamine API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tromethamine API manufacturer or Tromethamine API supplier.
PharmaCompass also assists you with knowing the Tromethamine API API Price utilized in the formulation of products. Tromethamine API API Price is not always fixed or binding as the Tromethamine API Price is obtained through a variety of data sources. The Tromethamine API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 108195-86-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 108195-86-4, including repackagers and relabelers. The FDA regulates 108195-86-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 108195-86-4 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 108195-86-4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 108195-86-4 supplier is an individual or a company that provides 108195-86-4 active pharmaceutical ingredient (API) or 108195-86-4 finished formulations upon request. The 108195-86-4 suppliers may include 108195-86-4 API manufacturers, exporters, distributors and traders.
click here to find a list of 108195-86-4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 108195-86-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of 108195-86-4 active pharmaceutical ingredient (API) in detail. Different forms of 108195-86-4 DMFs exist exist since differing nations have different regulations, such as 108195-86-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 108195-86-4 DMF submitted to regulatory agencies in the US is known as a USDMF. 108195-86-4 USDMF includes data on 108195-86-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 108195-86-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 108195-86-4 Drug Master File in Korea (108195-86-4 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 108195-86-4. The MFDS reviews the 108195-86-4 KDMF as part of the drug registration process and uses the information provided in the 108195-86-4 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 108195-86-4 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 108195-86-4 API can apply through the Korea Drug Master File (KDMF).
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108195-86-4 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 108195-86-4 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 108195-86-4 GMP manufacturer or 108195-86-4 GMP API supplier for your needs.
A 108195-86-4 CoA (Certificate of Analysis) is a formal document that attests to 108195-86-4's compliance with 108195-86-4 specifications and serves as a tool for batch-level quality control.
108195-86-4 CoA mostly includes findings from lab analyses of a specific batch. For each 108195-86-4 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.
108195-86-4 may be tested according to a variety of international standards, such as European Pharmacopoeia (108195-86-4 EP), 108195-86-4 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (108195-86-4 USP).