Page 2 - Drug Firms
Unichem Labs gets USFDA nod to market generic antidepressant tablets
Drug firm Unichem Laboratories on Thursday said it has received approval from the US health regulator to market generic Amitriptyline HCl tablets used in the treatment of depression. The company has received abbreviated new drug application (ANDA) approval to market its Amitriptyline HCl tablets USP, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a regulatory filing. The product is a generic version of AstraZeneca Pharmaceuticals LP's Elavil tablets in the same strengths, it added. The tablets will be commercialised from the company's Goa plant, Unichem Labs said. Amitriptyline HCl Tablets are indicated for the relief of symptoms of depression, it added. Shares of Unichem Laboratories closed at Rs 358.60 per scrip on BSE, up 7.43 per cent from its previous close.
 "Unichem Labs gets USFDA nod to market generic antidepressant tablets")
Retail investors miss rally in Gland Pharma; stock up 118% over IPO price
At the time of its IPO, retail investors bid for only 24 per cent or 0.24 times of the shares set aside for them
 "Retail investors miss rally in Gland Pharma; stock up 118% over IPO price")
Wockhardt in talks with global vaccine firms for contract manufacturing
UK site would fill-finish 100 mn doses of AstraZeneca vaccine, has 350 mn dose capacity; Aurangabad can make has 1 bn doses, vaccine raw materials
 "Wockhardt in talks with global vaccine firms for contract manufacturing")
As domestic sales decline, drug makers focus on exports to sustain growth
During April-July, drug makers exported products worth $ 7.4 billion, a growth of 9.5 per cent on year on year basis
 "As domestic sales decline, drug makers focus on exports to sustain growth")
Sun Pharma launches cheapest favipiravir brand in India, at Rs 35 a pill
Pricing pressure in this category is already visible as Glenmark revised its original price (Rs 103 per tablet) to Rs 79 per tablet within a month of the launch
 "Sun Pharma launches cheapest favipiravir brand in India, at Rs 35 a pill")
Coronavirus threat: Medical device firms see opportunity with rising demand
But drug firms brace for supply disruptions
 "Coronavirus threat: Medical device firms see opportunity with rising demand")
Indian pharmaceutical companies spread business to avoid regulatory ire
Increased USFDA import alerts could be reason for finding alternative sites
 "Indian pharmaceutical companies spread business to avoid regulatory ire")
Govt's new proposal: Pay fine for full batch if one drug found substandard
The provision will apply if the drug is found substandard or broken or if the bottle containing the drug in liquid form is damaged or leaking
 "Govt's new proposal: Pay fine for full batch if one drug found substandard")
After strong Q1, drug firms' revenue growth to dip to 7%, say analysts
The first quarter (Q1) of this financial year was a strong one for pharmaceutical players, driven by 28 per cent domestic growth on a GST-disrupted base
No coercive steps against drug firms for FDCs in market: Delhi HC
Around five pharma firms had filed writ petitions in the Delhi High Court challenging the September 7 notification by the Ministry of Health and Family Welfare
 "No coercive steps against drug firms for FDCs in market: Delhi HC")
200 'high-risk' drug firms come under Indian regulator lens
Centre, states jointly assess drug manufacturers' facilities
 "200 'high-risk' drug firms come under Indian regulator lens")
Brexit aftermath: Drug firms brace for new regulatory framework
According to experts, in the short term, there would not be any significant effects as the exit would take place only after two years
 "Brexit aftermath: Drug firms brace for new regulatory framework")
