Page 2 - Strides Pharma

Strides soars 11% on USFDA's tentative nod to generic HIV treatment drug

The company said it received a tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV

Strides Pharma arm gets USFDA tentative nod for generic HIV treatment drug

Strides Pharma Science Ltd on Thursday said its wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV. The approval granted by the US Food & Drug Administration (USFDA) is for Dolutegravir tablets of strength 50mg, Strides said in a statement. The Abbreviated New Drug Application (ANDA) is tentatively approved under USFDA's expedited review provision for the President's Emergency Plan for AIDS Relief, thereby qualifying the company to participate in global donor-funded programmes that procure this lifesaving medicine, it said. The medicine is supplied in 126 countries, it added. "As of full year 2022, donor procurement for Dolutegravir 50mg tablets is estimated at a value of USD 35 million. This product further strengthens the available offerings in HIV treatment from Strides," the company said. The approval adds to a list of products that Strides

Strides Pharma gets USFDA approval for generic Sevelamer Carbonate

Strides Pharma Science Ltd on Saturday said its arm, Strides Pharma Global Pte Ltd Singapore, has received approval from the US health regulator for its generic Sevelamer Carbonate for oral suspension indicated for patients with chronic kidney disease on dialysis to prevent dangerous increases in phosphates. The approval by the US Food & Drug Administration (USFDA) is for Sevelamer Carbonate for oral suspension of strengths 0.8g and 2.4g, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme, the company said. "The approval completes the company's Sevelamer Carbonate portfolio...The product is a complex generic with limited players having both the tablets and oral suspension," it said adding, the approved medicine will be manufactured at the company's facility in Bengaluru. The Sevelamer Carbonate market for both tablets and oral Suspension ..

Strides Pharma arm gets USFDA approval for generic Mycophenolate Mofetil

Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added. The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products, it added. The product will be manufactured at the company's facility in Bengaluru, Strides said. Mycophenolate Mofetil for oral suspension has a market size of USD 41 million, the company said citing IQVIA data.

Strides Pharma reports Q3 net loss of Rs 82 cr, revenue rises to Rs 865 cr

Strides Pharma Science on Tuesday reported a consolidated net loss of Rs 82 crore for the third quarter ended December 31, 2022. The drug firm had reported a net loss of Rs 127 crore in the October-December quarter of previous fiscal. Revenue from operations rose to Rs 865 crore for the quarter under review as against Rs 794 crore in the year-ago period, the company said in a regulatory filing. On a standalone basis, the company reported a net profit of Rs 12 crore as against a net loss of Rs 18 crore in the year-ago period, it added. The Bengaluru-based firm said the profit during the quarter was impacted by loss from JV and associates on account of inventory write off related to Covid portfolio. "We continue to focus on a profitable outcome for the business and have, by design, let go of several low margin businesses," Strides Pharma Science Founder, Managing Director and Executive Chairperson Arun Kumar said.

Strides Pharma gets USFDA nod for naproxen sodium softgel capsules

Strides Pharma Science Ltd on Thursday said its wholly-owned arm, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for generic naproxen sodium softgel capsules, used to treat pain or inflammation. The approval by the US Food & Drug Administration (USFDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter), the company said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference-listed drug, naproxen sodium capsules, 220 mg of Bionpharma Inc, it added. The product will be manufactured at the company's Bengaluru facility. Naproxen sodium softgel capsules is a nonsteroidal anti-inflammatory drug used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps, the company said. Strides said it is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, .

Stocks to watch: Telecom, Aviation, Tata Motors, HDFC, Glenmark Pharma

Stocks to watch today: Tata Motors UK subsidiary JLR is likely to halt production due to supply disruption and chip crunch; Aviation stocks in focus after jet fuel prices hiked by 16 per cent.

Strides Pharma arm gets EU-GMP certification for 2 facilities from Hungary

Strides Pharma Science on Thursday said its subsidiary has received EU-GMP certification for two of its manufacturing facilities from Hungary's National Institute of Pharmacy and Nutrition

Stocks to Watch: Adani Ports, Strides, Metropolis, RITES, Zee, Balrampur

Stocks to Watch Today: Sugar and FMCG stocks likely to be in focus as govt limits sugar exports and exempts customs duty on agri cess. Apollo Hospitals, Bata, Coal India and Nalco to report results.

Strides Pharma Science signs pact with MPP to market Covid-19 drug

Branded as Kovidax, Strides' generic version of the Pfizer oral treatment will be launched in 95 markets as part of the sub-licensing agreement with Medicines Patent Pool (MPP), the drug firm said

Stocks to Watch: RIL, Zomato, M&M, Hindalco, Bharat Forge, MRF, Hero Moto

Apollo Hospitals, Ashok Leyland, Bajaj Hindusthan, Divis Labs, Fortis Healthcare, Glenmark, Godrej Industries, IDFC, India Cements, Jet Airways, PFC, Shree Renuka Sugars, Star Health and Voltas to ann

Strides Pharma records net loss of Rs 122 cr in Q3, revenue drops 5%

Company expects growth momentum in the US to pick up in coming quarters driven by new product launches

Strides Pharma's revenue drops 8% to Rs 736 crore in Sept quarter

A muted sales performance accompanied with a drop in gross margins and relatively higher operating costs has led to a negative operating leverage in the first half of FY22

Strides Pharma posts Rs 43 cr Q4 profit vs Rs 207 cr loss a year ago

Company to launch generic products to aid Covid-19 treatment in India, first being Liposomal Amphotericin B to treat black fungus

Stock picks by Sameet Chavan: Buy Strides Pharma, sell Grasim

We finally witnessed a decisive price and volume breakout from the recent congestion zone in Strides Pharma

Stelis Biopharma raises $195 mn for vaccination unit, contract business

Vaccine unit will manufacture up to 800 million doses of vaccines annually

India's Stelis Biopharma to make 200 mn doses of Sputnik V vaccine

India has now become one of the biggest producers of Sputnik V outside of Russia. Other countries that are producing it include South Korea, Brazil and China

Strides Pharma to spin off biopharma biz, start vaccines with global player

Entity Stelis Biopharma to require up to $100-mn additional funds in 3 years

Former HDFC Bank Managing Director Aditya Puri joins Strides Group

Former HDFC Bank managing director Aditya Puri has joined global pharma major Strides Group as an advisor and will also serve as a director of its associate company Stelis Biopharma.

Strides Pharma to set up 800-mn capacity vaccine suite in Bengaluru

In talks with global players seeking manufacturing opportunity for potential Covid-19 vaccine