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
State-of-the-art R&D lab expands technical feasibility capabilities for long-acting delivery of small molecules, biologics, nucleotides
As per the agreement, Lonza will provide commercial-scale manufacture of monoclonal antibodies
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
The company has already embarked upon significant expansion in Turkey
The distribution agreement is effective from 1 October 2021 and applies to Bormed products used in pharmaceutical packaging, medical and diagnostic devices
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 company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
2DG has been given emergency approval by the Drug Controller General of India (DCGI) for use on COVID-19 patients in the country
TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg
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