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Drug Approval | February 10, 2025
Briefs: Caplin Point Laboratories, Hikal and Cipla
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
The company anticipates 2025 worldwide sales to be between $64.1 billion and $65.6 billion
These results represent critical milestones for Philogen, as Fibromun has the potential to become second product to successfully complete multinational clinical trials with registration potential
The inspection was carried out from January 28 to February 1, 2025
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
EBITDA grew 46.9% YoY to Rs. 210.3 crore with EBITDA margin at 18.2%, grew 401 bps YoY and the reported PAT at Rs. 90 crore
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru
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Mesalazine is used to treat inflammatory bowel disease
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
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