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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 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.

12 May 2022
Admin
News Article

Alembic Pharma gets US FDA nod for generic Brovana inhalation solution

Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for arformoterol tartrate inhalation solution, 15 mcg (base)/2 mL Unit-dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. Arformoterol tartarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited. Arformoterol tartrate inhalation solution, 15 mcg (base)/2 mL Unit-dose vial, has an estimated market size of US$ 251 million for twelve months ending December 2021 according to IQVIA. Alembic has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from US FDA, including this second inhalational ANDA approval. Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

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