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API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36030
Submission : 2021-08-04
Status :
Type : II
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Drugs in Development
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ABOUT THIS PAGE
A Baricitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baricitinib, including repackagers and relabelers. The FDA regulates Baricitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baricitinib 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 Baricitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baricitinib supplier is an individual or a company that provides Baricitinib active pharmaceutical ingredient (API) or Baricitinib finished formulations upon request. The Baricitinib suppliers may include Baricitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Baricitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Baricitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Baricitinib active pharmaceutical ingredient (API) in detail. Different forms of Baricitinib DMFs exist exist since differing nations have different regulations, such as Baricitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baricitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Baricitinib USDMF includes data on Baricitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baricitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baricitinib 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 Baricitinib Drug Master File in Korea (Baricitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Baricitinib. The MFDS reviews the Baricitinib KDMF as part of the drug registration process and uses the information provided in the Baricitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Baricitinib 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 Baricitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Baricitinib suppliers with KDMF 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 Baricitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Baricitinib 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 Baricitinib 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 Baricitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Baricitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Baricitinib suppliers with NDC on PharmaCompass.
Baricitinib 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 Baricitinib 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 Baricitinib GMP manufacturer or Baricitinib GMP API supplier for your needs.
A Baricitinib CoA (Certificate of Analysis) is a formal document that attests to Baricitinib's compliance with Baricitinib specifications and serves as a tool for batch-level quality control.
Baricitinib CoA mostly includes findings from lab analyses of a specific batch. For each Baricitinib 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.
Baricitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Baricitinib EP), Baricitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Baricitinib USP).
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