FDA launches PreCheck program to bring drug manufacturing back to US
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
The company’s total income jumped 31% year-on-year to Rs 125.5 crore
The base Gland business posted ?11,790 million in revenue, up 16% YoY
The Tanuku facility will focus on the production of key therapeutic APIs, including Anti-Tussive, Anti-Coagulant (Blood Thinner), Anaesthetic, and Antidepressant molecules
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