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Real Generics’ Regulatory News Digest For Generics – 16 July 2015

EMA has issued product-specific bioequivalence guidance for: Sirolimus 0.5 mg, 1 mg and 2 mg coated tablets and 1mg/ml oral solution Sorafenib 200mg film-coated tablets Sunitinib 12.5mg, 25mg, 37.5mg and 50mg hard capsules Tadalafil 2.5mg, 5mg, 10mg and 20mg film-coated tablets Telithromycin 400 mg film-coated tablets Voriconazole 50 mg and 200 mg tablets and 40 […]

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