News | 21 July 2021
EMA grants ODD to Saroglitazar Mg
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
State-of-the-art R&D lab expands technical feasibility capabilities for long-acting delivery of small molecules, biologics, nucleotides
The company has reported PAT of Rs. 10.7 crore for Q1 FY22, higher by 23% YoY
As of 2025, the new Translational Science Center will offer room for more than 500 scientists, who will conduct research in a wide variety of fields ranging from the identification of disease biomarkers to the development of targeted therapies
As per the agreement, Lonza will provide commercial-scale manufacture of monoclonal antibodies
Growing R&D budgets of global pharmaceutical companies is the opportunity that Veeda and Bioneeds expect to capitalise on.
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.
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
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
Vikas Lifecare has already paid Rs. 25 million to the Advik bankers till date and the remaining amount shall also be paid within July 2021, making Advik a debt free company
The company has already embarked upon significant expansion in Turkey
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
In the interim, the statutory approvals obtained by the company under SEBI ICDR have lapsed in accordance with applicable law and are required to be re-obtained
The shareholders have also ratified the Board’s approval to allot 10 lakhs warrants to the Promoter, Managing Director and CEO, Mark Saldanha at the said price of Rs. 74 per warrant
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 first batch will be shipped to the Gamaleya Center for the quality control
The said batches have successfully passed all the checks for quality parameters both at the Gamaleya Center in Russia and at the Central Drug Laboratory, Kasauli in India
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