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Cipla receives USFDA approval for Phenylephrine HCL injection and Exemestane tablets

Cipla has announced that it has received USFDA approval for Phenylephrine HCL Injection and Exemestane 25mg Tablets. Both these products are manufactured at the company’s Goa plant as per its filling. The approval for Phenylephrine HCL Injection is for Pharmacy Bulk Package and Single Dose Vials.

Phenylephrine HCL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. This drug is sold under brand Vazculep by Avadel. Exemestane Tablets is a generic equivalent of Pfizer’s Aromasin which is indicated for the treatment of certain types of breast cancer in postmenopausal women.

Vazculep and its generics had US sales of ~$56mn for the 12-month period ending February 2018. Phenylephrine HCL is a low competition drug and that should benefit Cipla.

Aromasin and its generics had US sales of ~$77mn for the 12-month period ending February 2018. Aromasin (Exemestane) currently has 4 generic players and Cipla will be fifth and Cipla should be able to gain market share in this drug.

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