Cadila subsidiary gets USFDA approval for Haloperidol Decanoate Injection

Cadila Healthcare Limited's wholly owned subsidiary Liva Pharmaceuticals Ltd. has received USFDA approval for Haloperidol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL, single-dose vials, 250 mg (base)/5 mL (50 mg (base)/mL) and 500 mg (base)/5 mL (100 mg (base)/mL}, multiple-dose vials (US RLD - Haldol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL).

It will be manufactured at Liva Pharma's manufacturing facility at Vadodara. Haloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome.

Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. People with schizophrenia may seem like they have lost touch with reality. Tourette syndrome is a neurological disorder characterized by repetitive, stereotyped, involuntary movements and vocalizations called tics.

The group now has 274 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04.

Earlier this month, the company had announced that the USFDA inspected its Active Pharmaceutical Ingredients (API) manufacturing facility at Dabhasa, the group's largest API manufacturing site, from October 7-11, 2019. This was a CGMP audit and a pre-approval inspection (PAI). At the end of the inspection, no observation (483) was issued.

On Thursday, Cadila Healthcare was down 1.57 per cent to Rs 243.90 from its previous close of Rs 247.80. During the day, it made intra day high and low of Rs 250.35 and Rs 243.70 respectively.