The guidelines outlined the roles and responsibilities of the CDSCO’s Zonal, Sub-zonal, and Port offices and were released on September 12, marking the first update since 2011
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Under the agreement, Biocon Biologics is licensed to launch Bmab 1200 in the United States, scheduled for February 2025, subject to approval by the U.S. FDA
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For India and Indian companies to fulfil their enormous promise, a greater outlay towards research is paramount
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The shortest budget, very high on rhetoric, throws up serious questions which the discerning public demands answers, writes JK Dadoo
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This additional patent solidifies and augments the original invention, unveiling unique features with the potential to enhance precision and productivity across various applications
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The company received final approval for manufacturing and marketing Gabapentin tablets in 300 mg and 600 mg strengths, making it the first to receive such approval
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The approvals include five final approvals for medications such as Selexipag Tablets (multiple strengths), Dapsone gel (7.5 per cent), Fluorouracil Injection USP 5g/100mL (50 mg/mL), Carmustine for Injection USP 100 mg/vial, and Acyclovir Cream (5 per cent)
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This approval positions Lupin to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2 per cent, produced by Bausch & Lomb
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