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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.

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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

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04 Jun 2024
Admin
News Article

Lupin Receives US FDA Tentative Approval for Letermovir Tablets

Overview

Global pharma major Lupin Limited announced that it has received a tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for letermovir tablets, 240 mg and 480 mg, to market a generic equivalent of Prevymis tablets, 240 mg and 480 mg, of Merck Sharp & Dohme LLC. This product will be manufactured at Lupin’s Nagpur facility in India. Letermovir tablets

Letermovir tablets, 240 mg and 480 mg are indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.

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