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This "formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Sun Pharma's ANDA," Mayne Pharma said in a statement.
Sun Pharmaceutical Industries Ltd. was established by Dilip Shanghvi in 1983 in Calcutta, West Bengal with five psychiatry products and a two-person marketing team. Today it is ranked number one in share of prescriptions with 12 classes of doctors in India and a market leader in Psychiatry, Neurology, Cardiology, Orthopaedics, Gastroenterology, Nephrology, Diabetology, Dermatology, Urology ...
Zydus Lifesciences and Sun Pharmaceuticals have entered an agreement in October 2023 to co-market Desidustat. Sun Pharma will sell the drug as Rytstat , while Zydus will continue to sell it as Oxemia . [ 17 ]
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