News | July 21, 2021
Granules clears US FDA audit
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The company had announced the expected date of completion of sale and disposal of the said undertaking is 90 days from the date of signing the Definitive Agreements.
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
SteriScience will infuse an additional amount of Rs. 74.5 crore, making a total investment commitment of Rs. 114.5 crore in BSL
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
The companies anticipate clinical studies to begin in August, subject to regulatory approvals
The drug is used with other HIV medications to help control HIV infection and it helps to decrease the amount of HIV in one’s body so that the immune system can work better
2DG has been given emergency approval by the Drug Controller General of India (DCGI) for use on COVID-19 patients in the country
In addition to supporting the ongoing development of the first IND-approved product in clinical trials, the proceeds will also be used to expand the 3D printed drug product pipeline
ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials
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