Unichem in the spotlight
June 7, 2017
Unichem Laboratories Limited is pleased to inform that the Company’s formulations manufacturing facility at Ghaziabad has received an Establishment Inspection Report (EIR) from the USFDA. 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 USFDA. The inspection was carried out between 24th Feb 2017 to 3rd March 2017.
April 17, 2017
The Company has received ANDA approval from the United States Food and Drug Administration (USFDA) for Piroxicam Capsules USP 10mg & 20mg, which are therapeutically equivalent to Feldene Capsules 10mg & 20mg of Pfizer, Inc. Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA). For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once daily. If desired, the daily dose may be divided. Usually lowest effective dosage for the shortest duration, consistent with individual patient treatment goals is recommended. The product will be commercialized from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant.
March 08, 2017
Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg which are therapeutically equivalent to Maxalt – MLT Tablets 5mg & 10mg and Maxalt Tablets 5mg 10mg of Merck & Company, Inc.
March 06, 2017
The Company’s formulation manufacturing facility at Ghaziabad was inspected by the USFDA from February 24, 2017 to March 3, 2017. The two observations cited are, in the opinion of the Company, correctable ones in respect of which the Company will file the necessary response within the stipulated period of 15 working days. The observations do not impact business continuity and the Company’s supplies to the US market.
March 20, 2017
The Company’s Formulation manufacturing facility at Goa was inspected by USFDA from March 14th 2017 to March 20th 2017. There were few observations made, and these in the opinion of the Company are correctable ones in respect to which the Company will file the necessary response within the stipulated period of 15 working days. The observations do not impact business continuity and the Company’s supplies to the US market.