These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
India's bio economy has experienced remarkable growth, skyrocketing from $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company has received the GMP Certification after successful closure of the inspection
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million
Final decision from the European Commission is anticipated within the coming months
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
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