Unichem Lab gets tentative nod from USFDA for hydrochloride medicines
Category: #health  By Mateen Dalal  Date: 2019-05-08
  • share
  • Twitter
  • Facebook
  • LinkedIn

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

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

TPG Rise Climate Fund raises $5.4Bn to support new climate solutions
TPG Rise Climate Fund raises $5.4Bn to support new climate solutions
By Mateen Dalal

TPG Rise Climate Fund, the climate investing fund of TPG’s global impact investing platform TPG Rise, has recently raised its first close of $5.4 billion, bringing together an exclusive blend of funding from some of the top institutional invest...

Baby nutrition firm ByHeart nabs $90Mn in Series B funding round
Baby nutrition firm ByHeart nabs $90Mn in Series B funding round
By Mateen Dalal

ByHeart, a fully integrated infant nutrition company, has reportedly secured $90 million in Series B funding which the company plans to use for the launch of its baby formula and support the development of its pipeline of nutrition items for chi...

UAE extends travel ban for Indians amid strict COVID-19 guidelines
UAE extends travel ban for Indians amid strict COVID-19 guidelines
By Mateen Dalal

United Arab Emirates (UAE) has reportedly extended travel ban for individuals travelling from India and several other south Asian countries on the pretext of COVID-19 guidelines. As reported by Etihad Airlines, the ban will be followed till 31st July...