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List of Japan Drug Master File (JDMF) for Voclosporin Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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Looking for 515814-01-4 / Voclosporin API manufacturers, exporters & distributors?

Voclosporin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Voclosporin 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 Voclosporin manufacturer or Voclosporin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Voclosporin manufacturer or Voclosporin supplier.

PharmaCompass also assists you with knowing the Voclosporin API Price utilized in the formulation of products. Voclosporin API Price is not always fixed or binding as the Voclosporin Price is obtained through a variety of data sources. The Voclosporin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Voclosporin

Synonyms

515814-01-4, Lupkynis, Luveniq, Isatx-247, Voclosporin [usan], Isatx247

Cas Number

515814-01-4

Unique Ingredient Identifier (UNII)

2PN063X6B1

About Voclosporin

Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes. Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN. This [cyclosporine] A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN. Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.

Voclosporin Manufacturers

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.

Voclosporin Suppliers

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.

Voclosporin JDMF

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.

Voclosporin Manufacturers | Traders | Suppliers

Voclosporin Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Voclosporin

Get in contact with the supplier of your choice:

  1. Lonza Inc & Lonza America Inc
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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