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API SUPPLIERS
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39562
Submission : 2024-12-16
Status :
Type : II
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Registrant Name : Wooshin Labotach Co., Ltd.
Registration Date : 2025-07-28
Registration Number : Su579-5-ND
Manufacturer Name : Zakłady Farmaceutyczne Polp...
Manufacturer Address : Ul. Peplińska 19, Starogard Gdański, 83-200, Poland
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2025-01-14
Registration Number : Su30-8-ND
Manufacturer Name : Chunghwa Chemical Synthesis ...
Manufacturer Address : No.1, Tung-Hsing St., Shu-Lin, New Taipei City 23850, Taiwan
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Baricitinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Baricitinib manufacturer or Baricitinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baricitinib manufacturer or Baricitinib supplier.
A Baricitinib Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baricitinib Phosphate, including repackagers and relabelers. The FDA regulates Baricitinib Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baricitinib Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Baricitinib Phosphate supplier is an individual or a company that provides Baricitinib Phosphate active pharmaceutical ingredient (API) or Baricitinib Phosphate finished formulations upon request. The Baricitinib Phosphate suppliers may include Baricitinib Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Baricitinib Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Baricitinib Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Baricitinib Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Baricitinib Phosphate DMFs exist exist since differing nations have different regulations, such as Baricitinib Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baricitinib Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Baricitinib Phosphate USDMF includes data on Baricitinib Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baricitinib Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baricitinib Phosphate 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 Phosphate Drug Master File in Korea (Baricitinib Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Baricitinib Phosphate. The MFDS reviews the Baricitinib Phosphate KDMF as part of the drug registration process and uses the information provided in the Baricitinib Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Baricitinib Phosphate 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 Phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Baricitinib Phosphate suppliers with KDMF on PharmaCompass.
A Baricitinib Phosphate written confirmation (Baricitinib Phosphate WC) is an official document issued by a regulatory agency to a Baricitinib Phosphate manufacturer, verifying that the manufacturing facility of a Baricitinib Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Baricitinib Phosphate APIs or Baricitinib Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Baricitinib Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Baricitinib Phosphate 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 Baricitinib Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Baricitinib Phosphate 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 Phosphate 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 Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Baricitinib Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Baricitinib Phosphate suppliers with NDC on PharmaCompass.
Baricitinib Phosphate 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 Phosphate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Baricitinib Phosphate GMP manufacturer or Baricitinib Phosphate GMP API supplier for your needs.
A Baricitinib Phosphate CoA (Certificate of Analysis) is a formal document that attests to Baricitinib Phosphate's compliance with Baricitinib Phosphate specifications and serves as a tool for batch-level quality control.
Baricitinib Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Baricitinib Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Baricitinib Phosphate EP), Baricitinib Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Baricitinib Phosphate USP).
