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Granules India secures first-to-file ANDA for Sodium Oxybate

6 Jul 2026via NSE FilingSource

Granules India secures first-to-file ANDA for Sodium Oxybate Extended-Release for Oral Suspension. This milestone could lead to 180-day marketing exclusivity upon FDA approval. The drug has a US market size of $400 million annually. Approval may boost revenues significantly in the coming years.

📊 STOCKS: GRANULES | 🏢 SECTOR: Pharma | #MEDIUMIMPACT #Pharma

#Pharma#FDA#ANDA

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⚠️ This brief is AI-generated from public news sources for informational purposes only. Not investment advice. Always consult a SEBI-registered advisor before trading.

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