Unichem Lab gets tentative nod from USFDA for hydrochloride medicines
These tablets are indicated for nasal decongestant and antihistamine Unichem may produce and market the generic drug products after approval Reports confirm that Unichem Laboratories has been granted a tentative ANDA approval by the United States Food and Drug Administration (USFDA) for Unichem's Pseudoephedrine Hydrochloride and Cetirizine Hydrochloride Extended-Release Tablets USP, in the strengths of 120 mg/ 5mg. Apparently, the firm would be marketing a generic version of Johnson & Johnson’s Zyrtec-D 12 Hour extended tablets (Pseudoephedrine Hydrochloride/Cetirizine Hydrochloride, 120mg/5 mg). These tablets are indicated for nasal decongestant and antihistamine. On receipt of final approval, the product will be commercialized from Unichemls Goa Plant. ANDA, or Abbreviated New Drug Approval, is a kind of application in U.S. for a generic drug approval for a currently licensed approved drug. After approval, the company may produce and market the generic drug products. On the day of the news, the shares of Unichem Laboratories were trading at Rs 188.50, which a Rs 2.15 or 1.15% hike over previous day closing at Rs 186.35. The scrip reportedly opened at Rs. 186.35 and registered a high of Rs 189.95 and a low of Rs. 185.50, with the market capitalization of the company being around Rs 1,311.59 crores. In the previous year, Unichem Laboratories had informed that its active pharmaceutical ingredient manufacturing units at Roha and Pithampura had received Establishment Inspection Reports from the United States Food and Drug Administration (USFDA). This specified the closure of inspections at the both the plant. The inspection at Roha unit was held between July 30 and August 3 while inspection at Pithampura unit was held between July 23 to July 27. For the uninitiated, Unichem Laboratories Limited is an international, specialty pharmaceutical company. It is engaged in producing and marketing of pharmaceutical formulations as branded generics and in various markets globally. In India, the company is leading in niche therapy zones of neurology, cardiology, anti-infectives, and orthopedics. The company excels in manufacturing of complex API and dosage forms, process chemistry, as well as in product development. Source Credit: https://www.business-standard.com/article/news-cm/unichem-laboratories-receives-approval-from-usfda-for-hydrocloride-tablets-119050700345_1.html