Intambwe yakira USFDA ibyemezo bya Tetracycline Hydrochloride Capsules

Strides Pharma Science Limited (Strides) uyumunsi yatangaje ko kuva ku butegetsi kuva ku butegetsi bwose, Strides Pharma Global Pte. Limited, Singapore, yakiriye uruhushya rwa Tetracycline Hydrochloride Capsules USP, mg 250 na mg 500 ziva muri Amerika ishinzwe ibiryo n'ibiyobyabwenge (USFDA). Igicuruzwa ni verisiyo rusange ya Achromycin V Capsules, mg 250 na mg 500, za Avet Pharmaceuticals Inc (mbere Heritage Pharmaceuticals Inc.) Dukurikije imibare ya IQVIA MAT, isoko ryo muri Amerika kuri Tetracycline Hydrochloride Capsules USP, mg 250 na mg 500 ni hafi US $ 16 Mn. Ibicuruzwa bizakorerwa mu kigo cyamamaye cy’isosiyete i Bangalore kandi bizashyirwa ku isoko na Strides Pharma Inc. ku isoko ry’Amerika.Isosiyete ifite amadosiye 123 ya ANDA yatanzwe na USFDA muri yo hakaba haremewe ANDAs 84 naho 39 zikaba zitegereje kwemezwa.Tetracycline Hydrochloride Capsule ni antibiyotike ikoreshwa mu kuvura indwara nyinshi ziterwa na bagiteri zuruhu, amara, inzira zubuhumekero, inzira yinkari, imyanya ndangagitsina, lymph node, nibindi sisitemu y'umubiri. Rimwe na rimwe, tetracycline Hydrochloride Capsule ikoreshwa mugihe penisiline cyangwa indi antibiotique idashobora gukoreshwa mu kuvura indwara zikomeye nka Anthrax, Listeria, Clostridium, Actinomyces. Imigabane ya Strides Pharma Science Ltd iheruka gucuruza muri BSE ku mafaranga 466.65 ugereranije na mbere yo gufunga amafaranga 437. Umubare rusange wimigabane yagurishijwe kumunsi ni 146733 mubucuruzi burenga 5002. Umugabane wageze kumunsi wo hejuru wa 473.4 no munsi yumunsi wa 440.Ubucuruzi bwinjiza kumunsi bwari amafaranga 66754491.


Igihe cyo kohereza: Apr-29-2020