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VMF
DRUG PRODUCT COMPOSITIONS
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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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-22
Pay. Date : 2022-05-04
DMF Number : 36542
Submission : 2022-06-03
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
4-Chloro-7H-pyrrolo[2,3-d]pyrimidine
CAS Number : 3680-69-1
End Use API : Tofacitinib Citrate
About The Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With fa...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
(3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidina...
CAS Number : 1062580-52-2
End Use API : Tofacitinib Citrate
About The Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With fa...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
4-Chloropyrrolo[2,3-d]pyrimidine
CAS Number : 3680-69-1
End Use API : Tofacitinib Citrate
About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(3R,4R)-N,4-Dimethyl-1 (phenylmethyl)-3-piperidina...
CAS Number : 1062580-52-2
End Use API : Tofacitinib Citrate
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 mete...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
4-Chloro-7-[(4- methylphenyl)sulfonyl]-7H- pyrrolo...
CAS Number : 479633-63-1
End Use API : Tofacitinib Citrate
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 mete...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
(3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidina...
CAS Number : 1062580-52-2
End Use API : Tofacitinib Citrate
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Indian Drugs & Chemicals – delivering trusted APIs, intermediates & fine chemicals worldwide with 40+ years of quality expertise.
4-Chloro-5h-pyrrolo[3,2-d] Pyrimidine
CAS Number : 84905-80-6
End Use API : Tofacitinib Citrate
About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Softgels
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
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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]Neelkanth MineChem
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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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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Direct Compression
Film Formers & Plasticizers
Granulation
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Lubricants & Glidants
Co-Processed Excipients
Coating Systems & Additives
Taste Masking
Chewable & Orodispersible Aids
Solubilizers
Controlled & Modified Release
Parenteral
Topical
Emulsifying Agents
Rheology Modifiers
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Tofacitinib Citrate 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 Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier.
A Tofacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tofacitinib, including repackagers and relabelers. The FDA regulates Tofacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tofacitinib 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 Tofacitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tofacitinib supplier is an individual or a company that provides Tofacitinib active pharmaceutical ingredient (API) or Tofacitinib finished formulations upon request. The Tofacitinib suppliers may include Tofacitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Tofacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tofacitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tofacitinib active pharmaceutical ingredient (API) in detail. Different forms of Tofacitinib DMFs exist exist since differing nations have different regulations, such as Tofacitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tofacitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Tofacitinib USDMF includes data on Tofacitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tofacitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tofacitinib 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 Tofacitinib Drug Master File in Japan (Tofacitinib JDMF) empowers Tofacitinib 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 Tofacitinib JDMF during the approval evaluation for pharmaceutical products. At the time of Tofacitinib 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 Tofacitinib 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 Tofacitinib Drug Master File in Korea (Tofacitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tofacitinib. The MFDS reviews the Tofacitinib KDMF as part of the drug registration process and uses the information provided in the Tofacitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tofacitinib 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 Tofacitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tofacitinib suppliers with KDMF on PharmaCompass.
A Tofacitinib written confirmation (Tofacitinib WC) is an official document issued by a regulatory agency to a Tofacitinib manufacturer, verifying that the manufacturing facility of a Tofacitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tofacitinib APIs or Tofacitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Tofacitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Tofacitinib 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 Tofacitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tofacitinib 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 Tofacitinib 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 Tofacitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tofacitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tofacitinib suppliers with NDC on PharmaCompass.
Tofacitinib 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 Tofacitinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tofacitinib GMP manufacturer or Tofacitinib GMP API supplier for your needs.
A Tofacitinib CoA (Certificate of Analysis) is a formal document that attests to Tofacitinib's compliance with Tofacitinib specifications and serves as a tool for batch-level quality control.
Tofacitinib CoA mostly includes findings from lab analyses of a specific batch. For each Tofacitinib 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.
Tofacitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Tofacitinib EP), Tofacitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tofacitinib USP).
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