Wetter Pharma-Fertigungs GmbH & Co. KG (manufacturing, primary packaging, visual inspection, batch testing; description, identification by infrared (IR) spectroscopy, quantitative determination of fulvestrant by high-performance liquid chromatography (HPLC), degradation products by HPLC, volume of injectable solution in containers, functional testing of PFS, bacterial endotoxins, mechanical particulates (sub-visible particles), sterility, ethanol content by gas chromatography (GC), benzyl alcohol content by GC, benzyl benzoate content by GC; visual inspection; visual inspection, batch testing (sterility testing); manufacturing, primary packaging, visual inspection, batch testing; description, identification by infrared (IR) spectroscopy, quantitative determination of fulvestrant by high-performance liquid chromatography (HPLC), degradation products by HPLC, volume of injectable solution in containers, functional testing of PFS, bacterial endotoxins, mechanical particulates (sub-visible particles), sterility, ethanol content by gas chromatography (GC), benzyl alcohol content by GC, benzyl benzoate content by GC)

Ukraine

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