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API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Minakem is manufacturing small molecules APIs including corticosteroids
NDC 
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.
EU-WC
NDC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
BR
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC
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USDMF
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33332
Submission : 2018-12-21
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35976
Submission : 2021-05-29
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-06
Pay. Date : 2024-01-31
DMF Number : 38994
Submission : 2023-12-02
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-15
DMF Number : 37164
Submission : 2022-07-29
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 : 37532
Submission : 2022-10-28
Status :
Type : II
Mesochem is focused on incessant innovation along with the R&D of new APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32445
Submission : 2018-01-22
Status :
Type : II
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Drugs in Development
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Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
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ABOUT THIS PAGE
A Xeljanz manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xeljanz, including repackagers and relabelers. The FDA regulates Xeljanz manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xeljanz 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 Xeljanz manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xeljanz supplier is an individual or a company that provides Xeljanz active pharmaceutical ingredient (API) or Xeljanz finished formulations upon request. The Xeljanz suppliers may include Xeljanz API manufacturers, exporters, distributors and traders.
click here to find a list of Xeljanz suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xeljanz DMF (Drug Master File) is a document detailing the whole manufacturing process of Xeljanz active pharmaceutical ingredient (API) in detail. Different forms of Xeljanz DMFs exist exist since differing nations have different regulations, such as Xeljanz USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xeljanz DMF submitted to regulatory agencies in the US is known as a USDMF. Xeljanz USDMF includes data on Xeljanz's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xeljanz USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xeljanz 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 Xeljanz Drug Master File in Japan (Xeljanz JDMF) empowers Xeljanz 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 Xeljanz JDMF during the approval evaluation for pharmaceutical products. At the time of Xeljanz 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 Xeljanz 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 Xeljanz Drug Master File in Korea (Xeljanz KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xeljanz. The MFDS reviews the Xeljanz KDMF as part of the drug registration process and uses the information provided in the Xeljanz KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xeljanz 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 Xeljanz API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xeljanz suppliers with KDMF on PharmaCompass.
A Xeljanz written confirmation (Xeljanz WC) is an official document issued by a regulatory agency to a Xeljanz manufacturer, verifying that the manufacturing facility of a Xeljanz active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xeljanz APIs or Xeljanz finished pharmaceutical products to another nation, regulatory agencies frequently require a Xeljanz WC (written confirmation) as part of the regulatory process.
click here to find a list of Xeljanz 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 Xeljanz as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xeljanz 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 Xeljanz 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 Xeljanz and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xeljanz NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xeljanz suppliers with NDC on PharmaCompass.
Xeljanz 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 Xeljanz 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 Xeljanz GMP manufacturer or Xeljanz GMP API supplier for your needs.
A Xeljanz CoA (Certificate of Analysis) is a formal document that attests to Xeljanz's compliance with Xeljanz specifications and serves as a tool for batch-level quality control.
Xeljanz CoA mostly includes findings from lab analyses of a specific batch. For each Xeljanz 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.
Xeljanz may be tested according to a variety of international standards, such as European Pharmacopoeia (Xeljanz EP), Xeljanz JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xeljanz USP).
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