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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
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
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
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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, Price,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.
PharmaCompass also assists you with knowing the Tofacitinib Citrate API Price utilized in the formulation of products. Tofacitinib Citrate API Price is not always fixed or binding as the Tofacitinib Citrate Price is obtained through a variety of data sources. The Tofacitinib Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CP 690550 citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CP 690550 citrate, including repackagers and relabelers. The FDA regulates CP 690550 citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CP 690550 citrate 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 CP 690550 citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CP 690550 citrate supplier is an individual or a company that provides CP 690550 citrate active pharmaceutical ingredient (API) or CP 690550 citrate finished formulations upon request. The CP 690550 citrate suppliers may include CP 690550 citrate API manufacturers, exporters, distributors and traders.
click here to find a list of CP 690550 citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CP 690550 citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of CP 690550 citrate active pharmaceutical ingredient (API) in detail. Different forms of CP 690550 citrate DMFs exist exist since differing nations have different regulations, such as CP 690550 citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CP 690550 citrate DMF submitted to regulatory agencies in the US is known as a USDMF. CP 690550 citrate USDMF includes data on CP 690550 citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CP 690550 citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CP 690550 citrate 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 CP 690550 citrate Drug Master File in Japan (CP 690550 citrate JDMF) empowers CP 690550 citrate 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 CP 690550 citrate JDMF during the approval evaluation for pharmaceutical products. At the time of CP 690550 citrate 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 CP 690550 citrate 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 CP 690550 citrate Drug Master File in Korea (CP 690550 citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CP 690550 citrate. The MFDS reviews the CP 690550 citrate KDMF as part of the drug registration process and uses the information provided in the CP 690550 citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a CP 690550 citrate 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 CP 690550 citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CP 690550 citrate suppliers with KDMF on PharmaCompass.
A CP 690550 citrate written confirmation (CP 690550 citrate WC) is an official document issued by a regulatory agency to a CP 690550 citrate manufacturer, verifying that the manufacturing facility of a CP 690550 citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CP 690550 citrate APIs or CP 690550 citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a CP 690550 citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of CP 690550 citrate 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 CP 690550 citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CP 690550 citrate 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 CP 690550 citrate 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 CP 690550 citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CP 690550 citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CP 690550 citrate suppliers with NDC on PharmaCompass.
CP 690550 citrate 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 CP 690550 citrate 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 CP 690550 citrate GMP manufacturer or CP 690550 citrate GMP API supplier for your needs.
A CP 690550 citrate CoA (Certificate of Analysis) is a formal document that attests to CP 690550 citrate's compliance with CP 690550 citrate specifications and serves as a tool for batch-level quality control.
CP 690550 citrate CoA mostly includes findings from lab analyses of a specific batch. For each CP 690550 citrate 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.
CP 690550 citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (CP 690550 citrate EP), CP 690550 citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CP 690550 citrate USP).
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