Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis
The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam
The company will engage with the agency to resolve the import alert at the earliest.
Granules now have a total of 53 ANDA approvals from USFDA
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions
The company has been issued ‘Form 483’ with two observations
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
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
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