This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
The facility was inspected from May 7 to May 17, 2024
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The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government
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