The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
The company has secured 506 marketing approvals for its oncology products across 76 countries.
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
With this, the number of marketing approvals for its oncology products across 75 countries has gone up to 503
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region
Company intends to increase sales in the UK to approximately 2 million Euros by focusing on seven molecules which are already registered in the country
Pre-filled pens containing a combination of insulin glargine 100 Units/mL and lixisenatide for once-daily dosing
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
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