Page 9 - Pharmaceutical Firms

Glenmark arm recalls two products in US due to manufacturing issues

Drug firm Glenmark is recalling two products in the US due to manufacturing issues, according to the US Food and Drug Administration. New Jersey-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharmaceuticals, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray. The company is recalling the affected lot due to "defective delivery system", the US Food and Drug Administration (USFDA) said in its latest enforcement report. "The dip tube is clogged causing the spray not to work," it added. Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24 this year. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The US health regulator said the drug firm is also ...

GSK agrees to settle about 80,000 Zantac lawsuits for up to $2.2 billion

Lawsuits against the companies began piling up in both state and federal courts after the US Food and Drug Administration in 2020 asked manufacturers to pull Zantac off the market

'India's pharma exports expected to remain strong amid global slowdown'

Exports of India's pharmaceutical and meditech sectors are expected to sustain the growth momentum in the ongoing fiscal despite a slowdown in the global economy, a senior government official said on Wednesday. With the government revving up support for drug development in India, as many as 16 blockbuster molecules targeted for a wide range of therapeutic areas, including cancer, diabetes, HIV and tuberculosis, are in the pipeline to be produced in India, Department of Pharmaceuticals, Secretary Arunish Chawla told reporters on the sidelines of CII Pharma and Life Sciences summit here. "We have been analysing the export trends in the recent data. Even though there is a general slowdown in exports globally, the good news is that the Indian pharmaceuticals, biotech, and bulk drug exports have grown double-digit over the last year," he said in response to a query on export prospects of the pharma industry amid a global slowdown. He further said,"In the first four months of this year, .

CVS Health likely to explore options including potential break-up

CVS is led by healthcare industry veteran Karen Lynch, who previously headed the Aetna unit and is temporarily overseeing the business with Chief Financial Officer Tom Cowhey

Regulatory, policy reforms crucial for future of India's pharma R&D: Report

India's regulatory and policy reforms are crucial for shaping the future of pharmaceutical research and development by streamlining approval processes, strengthening IP protections and incentivising innovation, as several policy challenges continue to hinder the growth of R&D in the sector, according to a report. As the country modernises its regulatory framework and enhances collaboration with global regulatory agencies, India is well-positioned to become a global leader in pharmaceutical innovation, as per the report by Deloitte and industry chamber ASSOCHAM. It acknowledged that India's pharmaceutical ecosystem is transforming significantly, supported by comprehensive regulatory and policy reforms to foster innovation and growth. The regulatory framework, which governs drug discovery, development and commercialisation, is being actively enhanced to streamline approval processes, increase transparency and reduce barriers to entry for innovative products. However, the report ...

Carlyle-backed SeQuent, Viyash Life Sciences announce Rs 8,000 crore merger

Rs 8,000 crore merger will create one of the largest animal health companies in India

Pharmaceutical firm Piramal Pharma eyes to double revenue to $2 bn by FY30

Eyeing tripling of Ebitda and bringing down net debt during the same period

Akums Drugs gets patent for formulation to manage sickle cell disease

Akums Drugs and Pharmaceuticals on Friday said it has received patent for a formulation for Sickle Cell Disease (SCD). The company has received a patent from India patent office for its room temperature stable oral suspension of Hydroxyurea, a formulation aimed at managing SCD. "Our constant endeavor is to work on affordable medicines for Orphan Drugs and reduce dependency on imported medicines ensuring patient safety from rare diseases with timely and necessary treatment," Akums Managing Director Sanjeev Jain said in a statement. SCD, a genetic blood disorder, leads to severe health complications such as anaemia, frequent pain episodes and other debilitating symptoms, affecting millions worldwide, especially in India and Africa. Akums said its formulation will come at a fraction of the cost of imported Hydroxyurea solution.

This SME stock has surged 61% in 12 days; zoomed 328% in 3 months

Shares of Sudarshan Pharma Industries were frozen in upper circuit of 5 per cent at Rs 274.50, which is also the new high it hit on the BSE in Thursday's intra-day trade.

Indian pharmaceutical market registers over 6% growth in August 2024

Sheetal Sapale, vice-president (commercial) at Pharmarack, said that new introductions and price growth have driven the market growth for the month of August 2024

Entod Pharma denies false claims in media regarding PresVu Eye Drops

The company further mentioned that the opinions and claims printed in news stories do not represent Entod Pharmaceuticals

Antibiotic production waste fuelling drug-resistant bacteria, warns WHO

In a first, the World Health Organization (WHO) has issued norms on managing waste during antibiotic production

Akums Drugs strengthens global presence with European market expansion

The decision to enter the European market comes at a time when the global pharmaceutical landscape is undergoing changes

India's pharma sector set for 9.6% CAGR, reaching $55 bn by 2030: Report

Key segments contributing to the growth of India's pharma sector will be patented drugs, branded generics, and trade generics, according to a report by Pharmarack Technologies

Shilpa Medicare hits fresh high on successful trial of liver fibrosis drug

Shares of Shilpa Medicare were trading at Rs 733.15, up by nearly Rs 36, or 5.15 per cent on the BSE. In contrast, the 30-stock BSE Sensex was trading at 81,714 levels, up 0.77 per cent.

Wanbury jumps 4% after firm gets zero form 483 observations from USFDA

Shares of pharma company Wanbury climbed nearly 4 per cent on Friday after the company received an EIR with zero form 483 observations, from the USFDA

Aarti Drugs surges 13% as board mulls share buyback on August 26

Going ahead in FY25, the management anticipates an improvement in margins, mostly driven by an anticipated growth in export sales and backward integration.

At least 15 injured in reactor explosion at Andhra Pradesh chemical factory

The blast occurred at the Escientia Chemical Factory in Rambilli, leading to a fire at the facility. The injured workers were transported to a nearby hospital for treatment

Aurobindo Pharma arm gets warning letter from USFDA for Telangana unit

Aurobindo Pharma Ltd on Friday said its arm Eugia Pharma Specialities Ltd received a warning letter from the US health regulator for its formulations manufacturing unit in Telangana. Earlier in May, the company had stated that Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, received Official Action Indicated (OAI) status by the US Food and Drug Administration (USFDA). "Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing. It did not elaborate on the details of the warning by the regulator. "There is no impact on the existing supplies to the US markets," the company said. Aurobindo Pharma said it remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis. The USFDA had conducted an inspection at Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd, located at Pashamylaram, Patancheru Mandal, ..

Clinical trial waiver only if drugs have greater benefits, says govt

A senior official in the health ministry said that the rule will help to make available essential drugs that have a significant therapeutic advance over the current standard care