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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...
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ABOUT THIS PAGE
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PharmaCompass offers a list of DOTA 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 DOTA manufacturer or DOTA supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred DOTA manufacturer or DOTA supplier.
PharmaCompass also assists you with knowing the DOTA API Price utilized in the formulation of products. DOTA API Price is not always fixed or binding as the DOTA Price is obtained through a variety of data sources. The DOTA Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DOTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DOTA, including repackagers and relabelers. The FDA regulates DOTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DOTA 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 DOTA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DOTA supplier is an individual or a company that provides DOTA active pharmaceutical ingredient (API) or DOTA finished formulations upon request. The DOTA suppliers may include DOTA API manufacturers, exporters, distributors and traders.
click here to find a list of DOTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DOTA DMF (Drug Master File) is a document detailing the whole manufacturing process of DOTA active pharmaceutical ingredient (API) in detail. Different forms of DOTA DMFs exist exist since differing nations have different regulations, such as DOTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DOTA DMF submitted to regulatory agencies in the US is known as a USDMF. DOTA USDMF includes data on DOTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DOTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DOTA 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 DOTA Drug Master File in Korea (DOTA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DOTA. The MFDS reviews the DOTA KDMF as part of the drug registration process and uses the information provided in the DOTA KDMF to evaluate the safety and efficacy of the drug.
After submitting a DOTA 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 DOTA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DOTA suppliers with KDMF on PharmaCompass.
DOTA 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 DOTA 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 DOTA GMP manufacturer or DOTA GMP API supplier for your needs.
A DOTA CoA (Certificate of Analysis) is a formal document that attests to DOTA's compliance with DOTA specifications and serves as a tool for batch-level quality control.
DOTA CoA mostly includes findings from lab analyses of a specific batch. For each DOTA 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.
DOTA may be tested according to a variety of international standards, such as European Pharmacopoeia (DOTA EP), DOTA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DOTA USP).
