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In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through Lactation Day 20

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The article points to the timing rules: an empty stomach, a gap before food or other medications, and specific instructions about water

ResearchGate - Preclinical safety evaluation of body protective compound-157: Summarizes preclinical safety data in animals

This rejection means generic manufacturers in India can produce semaglutide immediately