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

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

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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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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.

01 Oct 2022
Admin
News Article

Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder. The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the These are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome. "It is possible that our ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses

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