Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
The players and management of Mumbai City FC presented patients with exclusive gifts, symbolizing support and appreciation for their fight against cancer
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company has been issued ‘Form 483’ with two observations
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
The company was chosen for this transformative exercise due to its deep expertise in the healthcare vertical, coupled with its digital engineering and cloud capabilities, a vast partner network, and long-term relationship with the client
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