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API SUPPLIERS
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USDMF
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Rochem International Inc
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Droxidopa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Droxidopa, including repackagers and relabelers. The FDA regulates Droxidopa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Droxidopa 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 Droxidopa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Droxidopa supplier is an individual or a company that provides Droxidopa active pharmaceutical ingredient (API) or Droxidopa finished formulations upon request. The Droxidopa suppliers may include Droxidopa API manufacturers, exporters, distributors and traders.
click here to find a list of Droxidopa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Droxidopa DMF (Drug Master File) is a document detailing the whole manufacturing process of Droxidopa active pharmaceutical ingredient (API) in detail. Different forms of Droxidopa DMFs exist exist since differing nations have different regulations, such as Droxidopa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Droxidopa DMF submitted to regulatory agencies in the US is known as a USDMF. Droxidopa USDMF includes data on Droxidopa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Droxidopa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Droxidopa suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Droxidopa Drug Master File in Japan (Droxidopa JDMF) empowers Droxidopa API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Droxidopa JDMF during the approval evaluation for pharmaceutical products. At the time of Droxidopa JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Droxidopa suppliers with JDMF 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 Droxidopa Drug Master File in Korea (Droxidopa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Droxidopa. The MFDS reviews the Droxidopa KDMF as part of the drug registration process and uses the information provided in the Droxidopa KDMF to evaluate the safety and efficacy of the drug.
After submitting a Droxidopa 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 Droxidopa API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Droxidopa suppliers with KDMF on PharmaCompass.
A Droxidopa written confirmation (Droxidopa WC) is an official document issued by a regulatory agency to a Droxidopa manufacturer, verifying that the manufacturing facility of a Droxidopa active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Droxidopa APIs or Droxidopa finished pharmaceutical products to another nation, regulatory agencies frequently require a Droxidopa WC (written confirmation) as part of the regulatory process.
click here to find a list of Droxidopa suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Droxidopa as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Droxidopa API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Droxidopa as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Droxidopa and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Droxidopa NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Droxidopa suppliers with NDC on PharmaCompass.
Droxidopa 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 Droxidopa 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 Droxidopa GMP manufacturer or Droxidopa GMP API supplier for your needs.
A Droxidopa CoA (Certificate of Analysis) is a formal document that attests to Droxidopa's compliance with Droxidopa specifications and serves as a tool for batch-level quality control.
Droxidopa CoA mostly includes findings from lab analyses of a specific batch. For each Droxidopa 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.
Droxidopa may be tested according to a variety of international standards, such as European Pharmacopoeia (Droxidopa EP), Droxidopa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Droxidopa USP).
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