Page 3 - Pharma Industry

USFDA issues Form 483 with four observations to Dr Reddy's API unit

Dr Reddy's Laboratories on Friday said the US health regulator has issued Form 483 with four observations after inspecting its Andhra Pradesh-based API manufacturing facility. The US Food & Drug Administration (USFDA) today completed a GMP inspection at the company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the Hyderabad-based drug major said in a regulatory filing. The inspection was conducted from May 30, 2024 to June 7, 2024, it added. "We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the drug firm said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Delaware judge allows more than 70,000 Zantac lawsuits to go forward

In 2019, some manufacturers and pharmacies halted Zantac sales after a chemical called NDMA, which is known to cause cancer, was detected in some pills

FDA warns against infant formula by Texas firm due to contamination

US health officials warned parents to avoid powdered infant formula sold by a Texas dairy producer, because a dangerous bacteria was found in one of the company's products. The Food and Drug Administration issued the alert Friday on Crecelac Infant Powdered Goat Milk Infant Formula, after a sample collected from a Texas store tested positive for cronobacter, which can cause deadly infections in babies. The same bacteria sparked recalls and shortages of infant formula in 2022 after it was detected at a major US formula factory. The Crecelac formula was imported and distributed by Dairy Manufacturers Inc., of Prosper, Texas, according to the FDA. Press releases from the FDA and the company did not specify where the product was produced or how widely it was distributed in the US Messages left for the company on Friday were not immediately returned. Last week, the company voluntarily recalled the Crecelac formula and another brand, Farmalac, because they had not received approval by the

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...

WHO chief refers to Indian traditional medicine centre at Geneva address

World Health Organisation chief Tedros Adhanom Ghebreyesus on Monday referred to the Global Traditional Medicine Centre set up in India and the first global summit on traditional medicine hosted by the country as he underlined that the year 2023 was a productive one in the UN health agency's work supporting access to medicines and other health products. "We also established the Global Traditional Medicine Centre in India, and hosted the first global summit on traditional medicine," Ghebreyesus said in his remarks as he presented his report to the 77th World Health Assembly in Geneva. In March 2022, the Government of India and the UN health agency had signed an agreement to establish the WHO Global Centre for Traditional Medicine. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of peopl

AstraZeneca Q4 results: Net profit jumps 128%, revenue rises 34.59%

Strategic collaborations played a crucial role in AstraZeneca's achievements, particularly in enhancing diagnostic capabilities and treatment outcomes

Second-gen promoters more open to selling out: Rothschild MD Subhakanta Bal

In pharma areas like high potency APIs, sterile manufacturing capabilities, antibody drug conjugates, peptides etc are areas that are growing fast and there is an inherent entry barrier

Biocon signs licensing, supply deal for obesity drug in South Korea

Bengaluru-based company announces 'strategic partnership' with Handok

Dermatology segment in IPM poised for 11- 12% growth amid rising demand

The increasing incidence of skin diseases and the growing awareness about these conditions among the Indian populace have been pivotal in driving the dermatology market's expansion

Serum Institute ships its first set of malaria vaccine doses to Africa

The vaccine has been developed in collaboration with the University of Oxford and Novavax's Matrix-M adjuvant

Zydus Lifesciences Q4 results: Net profit sees 4-fold jump at Rs 1,182 cr

Indian generic drugmakers, which draw a significant share of revenue from the crucial U.S. market, are recovering from the effects of eroding prices in the largest drug market in the world

Zydus, MSN partner to license, supply affordable cancer tablets in the US

MSN Lab will manufacture and supply Cabozantinib; Zydus will handle marketing, distribution and sales

Pharma major Glenmark gets USFDA nod for generic ophthalmic solution

Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions. The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2 per cent/0.5 per cent, Glenmark said in a statement. The company's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent/0.5 per cent has been determined by the USFDA to be bioequivalent and therapeutically equivalent to Combigan ophthalmic solution, 0.2 per cent/0.5 per cent of AbbVie, Inc, it added. The solution will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it added. Combigan ophthalmic solution, 0.2 per cent/0.5 per cent achieved annual sales of approximately USD 290 million, the company said citing IQVIATM sales data

Cipla promoters sell 2.53% stake worth Rs 2,637 cr to fund philanthropy

ICICI Prudential MF, Aditya Birla Sun Life MF among top buyers

Mankind Pharma in fray to acquire Advent's stake in Bharat Serums: Report

Mankind Pharma's stock surged 3.11 per cent on BSE on Tuesday

US drug regulator delaying decision on RSV vaccine approval, says Moderna

The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, Moderna said Friday in a statement

Dr Reddy's Labs Q4 profit jumps 36% led by US growth, new products

During the quarter, the company launched 5 new products, of which 4 were launched in the US. A total of 21 products were launched during the year

Uttarakhand suspends licences of 14 products of Ramdev's pharma firms

SC had recently criticised Ramdev for not complying with its directives in an ongoing lawsuit to stop misleading advertisements of some of his traditional ayurvedic medicines

India becoming attractive for clinical trials, says pharma industry leaders

Over the past 10 years, clinical trials in India have become easier, more accessible and accelerated, experts from the pharma sector have said as top multinationals are increasingly looking at the country as their base for clinical trials. Data from 2017 to 2023 shows that phase two and phase three clinical trials are growing at about 15 per cent to 18 per cent in India. This is primarily because of the 10 modifications done to the Drugs and Cosmetics Act of 1940, according to Badhri Srinivasan, head of Global Clinical Operations, Novartis. Novartis is one of the largest pharmaceutical companies in the world and was the fourth largest by revenue in 2022. Given where we are, given what the landscape in the international community has happened, the regulators in India are starting to move and make changes to it. Since 2013, there have been 10 modifications to that act to try to make clinical trials easier, more accelerated, more accessible, et cetera, Srinivasan said at the 18th Annua

Zydus Lifesciences unit gets 10 observations from USFDA after inspection

Zydus Lifesciences on Wednesday said the US health regulator has issued ten observations after inspecting its injectable manufacturing plant near Vadodara in Gujarat. The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing. The inspection closed with ten observations, it added. The company will closely work with the USFDA to address and respond to the observations in an expeditious manner, Zydus Lifesciences said. Shares of the company were trading 2.79 per cent down at Rs 932.80 apiece on the BSE.