It strengthens Syngene’s portfolio as a fully integrated custom biomanufacturer with added mammalian and microbial capabilities for clinical and commercial supplies
The proposed acquisition will further bolster Strides US presence through acquisition of a multi dosage facility in the US.
The new greenfield manufacturing facility will be operated alongside the Guwahati facility as a parallel unit thereby helping mitigate the risks of a single-location operation
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection
The expanded laboratories and manufacturing facilities at Nansha are expected to come online between Q1 2022 and Q3 2022
This will enable Mangalam to reduce its reliability on Chinese imports for this product and also help to maintain an uninterrupted supply chain to a great extent
The GMP certificate is valid for three years until April 2024.
Applied Biosystems CoviPath COVID-19 RT-PCR Kit is approved for in vitro diagnostic use by ICMR and DCGI.
Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility
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