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Form:
solution for injection
ATC code:
L02BA03
Manufacturer:
Dr. Reddy's Laboratories Limited, Manufacturing Unit - 9
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Form:
solution for injection
ATC code:
L02BA03
Manufacturer:
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)
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Form:
solution for injection
ATC code:
L02BA03
Manufacturer:
K.T. ROMFARM COMPANY S.R.L. (manufacturing and primary packaging of medicinal product; physico-chemical control and batch release; secondary packaging and biological and microbiological control of medicinal product)
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Form:
solution for injection
ATC code:
L02BA03
Manufacturer:
EVER Pharma Jena GmbH (manufacturing of medicinal product, responsible for batch control and batch release; alternative unit for secondary packaging)
-
Form:
solution for injection
ATC code:
L02BA03
Manufacturer:
Laboratorios Echevarne, S.A. (manufacturer responsible for control of sterile products)