Unichem Laboratories receives tentative USFDA nod for sales of allergy drug

Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s Zyrtec-D 12-hour Extended tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Torrent Pharma completes acquisition of Unichem’s branded India business

Torrent Pharmaceuticals said it completed its previously announced acquisition of the branded formulation business of Unichem Laboratories for India and Nepal, including its Sikkim manufacturing facility. The deal was signed on 3rd November, 2017. With this, Torrent has entered the list of top pharma firms in the Indian market. “From today, Torrent begins the Integration […]

Unichem Labs says USFDA completes inspection of Goa facility

Unichem Laboratories said the US FDA has completed its inspection of the company’s formulations manufacturing facility in Goa. The facility has received an Establishment Inspection Report, the company added. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has now been closed by the […]

Unichem Labs Ghaziabad plant inspected by USFDA

Generic drug manufacturer Unichem Laboratories said its formulations manufacturing facility at Ghaziabad has successfully exited an inspection by the US Food and Drug Administration. It received an Establishment Inspection Report (EIR) from the USFDA, the company said. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). […]