US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Upadacitinib 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 Upadacitinib manufacturer or Upadacitinib supplier for your needs.
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PharmaCompass also assists you with knowing the Upadacitinib API Price utilized in the formulation of products. Upadacitinib API Price is not always fixed or binding as the Upadacitinib Price is obtained through a variety of data sources. The Upadacitinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Upadacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Upadacitinib, including repackagers and relabelers. The FDA regulates Upadacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Upadacitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Upadacitinib supplier is an individual or a company that provides Upadacitinib active pharmaceutical ingredient (API) or Upadacitinib finished formulations upon request. The Upadacitinib suppliers may include Upadacitinib API manufacturers, exporters, distributors and traders.
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A Upadacitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Upadacitinib active pharmaceutical ingredient (API) in detail. Different forms of Upadacitinib DMFs exist exist since differing nations have different regulations, such as Upadacitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Upadacitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Upadacitinib USDMF includes data on Upadacitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Upadacitinib 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 Upadacitinib Drug Master File in Korea (Upadacitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Upadacitinib. The MFDS reviews the Upadacitinib KDMF as part of the drug registration process and uses the information provided in the Upadacitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Upadacitinib 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 Upadacitinib API can apply through the Korea Drug Master File (KDMF).
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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 Upadacitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Upadacitinib 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 Upadacitinib 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 Upadacitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Upadacitinib NDC to their finished compounded human drug products, they may choose to do so.
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Upadacitinib 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 Upadacitinib 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 Upadacitinib GMP manufacturer or Upadacitinib GMP API supplier for your needs.
A Upadacitinib CoA (Certificate of Analysis) is a formal document that attests to Upadacitinib's compliance with Upadacitinib specifications and serves as a tool for batch-level quality control.
Upadacitinib CoA mostly includes findings from lab analyses of a specific batch. For each Upadacitinib 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.
Upadacitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Upadacitinib EP), Upadacitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Upadacitinib USP).