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