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API SUPPLIERS
Suanfarma, at the Core of a Better Life.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
NDC 
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-11
Pay. Date : 2024-07-19
DMF Number : 40162
Submission : 2024-08-01
Status :
Type : II
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ABOUT THIS PAGE
A Voclosporin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voclosporin, including repackagers and relabelers. The FDA regulates Voclosporin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voclosporin 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 Voclosporin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Voclosporin supplier is an individual or a company that provides Voclosporin active pharmaceutical ingredient (API) or Voclosporin finished formulations upon request. The Voclosporin suppliers may include Voclosporin API manufacturers, exporters, distributors and traders.
click here to find a list of Voclosporin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Voclosporin DMF (Drug Master File) is a document detailing the whole manufacturing process of Voclosporin active pharmaceutical ingredient (API) in detail. Different forms of Voclosporin DMFs exist exist since differing nations have different regulations, such as Voclosporin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Voclosporin DMF submitted to regulatory agencies in the US is known as a USDMF. Voclosporin USDMF includes data on Voclosporin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Voclosporin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Voclosporin 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 Voclosporin Drug Master File in Japan (Voclosporin JDMF) empowers Voclosporin 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 Voclosporin JDMF during the approval evaluation for pharmaceutical products. At the time of Voclosporin 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 Voclosporin suppliers with JDMF 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 Voclosporin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Voclosporin 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 Voclosporin 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 Voclosporin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Voclosporin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Voclosporin suppliers with NDC on PharmaCompass.
Voclosporin 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 Voclosporin 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 Voclosporin GMP manufacturer or Voclosporin GMP API supplier for your needs.
A Voclosporin CoA (Certificate of Analysis) is a formal document that attests to Voclosporin's compliance with Voclosporin specifications and serves as a tool for batch-level quality control.
Voclosporin CoA mostly includes findings from lab analyses of a specific batch. For each Voclosporin 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.
Voclosporin may be tested according to a variety of international standards, such as European Pharmacopoeia (Voclosporin EP), Voclosporin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Voclosporin USP).
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