1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

21 Nov 2024
Admin
News Article

UK MHRA Grants Marketing Authorization to Sparsentan for Immunoglobulin A Nephropathy

UK MHRA grants marketing authorization to sparsentan to treat adult patients with primary immunoglobulin A nephropathy

Overview

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the medicine sparsentan (Filspari) to treat primary immunoglobulin A nephropathy (IgAN).

Berger’s Disease

IgA neuropathy, also known as Berger’s disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in kidneys.

Sparsentan approval- Sparsentan was approved under the International Recognition Procedure (IRP), following route B.

Sparsentan: MOA

The active ingredient in Filspari, sparsentan, works by blocking the receptors for two hormones called endothelin and angiotensin.
Endothelin and angiotensin play a role in regulating processes in the kidney such as inflammation that lead to progression of kidney damage.
By blocking these receptors, Filspari lowers the amount of protein that leaks into the urine, and thereby helps to slow down progression of the disease.

Safety & Efficacy Analysis

As with any medicine, the MHRA will keep the safety and effectiveness of sparsentan under close review.
Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Marketing Authorisation –

The new marketing authorisation was granted on 06th November, 2024 to Vifor France under the International Recognition Procedure (IRP) Route B.
The Reference Regulator (RR) was the European Medicines Agency (EMA), with the procedure number (EMEA/H/C/005783/0000).

The MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.

Let’s apply Data-Driven Pricing to Your APIs

Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.

Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.

Start using market intelligence today and allow yourself to be in control in the API market.

Check it out today and make more informed sourcing decisions! Learn More!