Page 35 - Pharma Sector

Cytiva opens new manufacturing facility and experience center in Pune

The newly unveiled manufacturing facility in Pune will produce bioprocessing equipment, including tangential flow, virus filtration, and inactivation systems

Syrup samples of 2 pharma cos in TN, Gujarat found to have contaminants

Samples of syrups manufactured by two pharmaceutical companies based in Gujarat and Tamil Nadu have been found to have contaminants ethylene glycol and diethylene glycol, which were earlier detected in some syrups that were allegedly linked to deaths in the Gambia, Uzbekistan and Cameroon since last year, officials said. These are among 48 drugs, samples of which were declared as "not of standard quality" and "spurious" by the Central Drugs Standard Control Organisation (CDSCO), out of a total of 1,166 samples tested in August. Samples from a batch of cough syrup and another batch of anti-allergy syrup manufactured by Gujarat-based Norris Medicines Limited were found to be not of standard quality, containing 0.118 per cent ethylene glycol and 0.171 per cent ethylene glycol and 0.243 per cent diethylene glycol respectively. Norris Medicines Ltd was asked to suspend production at its Ankleshwar plant a month ago, an official said. Samples from three batches of COLD OUT syrup having .

BioTek CEO agrees to pay $20 million to settle kickback allegations

A speciality pharmacy company in the US and its Indian-origin chief executive officer have agreed collectively to pay USD 20 million to resolve allegations that they paid kickbacks to patients and physicians to protect its revenue stream, the justice department said. BioTek allegedly provided improper physician inducements and covered up kickbacks for patient referrals by waiving co-pays, said US Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. "BioTek's alleged scheme, orchestrated and implemented by Chaitanya Gadde, Dr David Tabby, and others, to routinely waive these copays -- without regard for whether the patients were experiencing financial hardship -- ensured a steady revenue stream for BioTek and undermined patient care to citizens of this District," Romero said in a statement. When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, .

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium Capsules

The product will be manufactured at Marksans Pharma's formulation manufacturing facility in Goa, India

IQuest Enterprises to acquire active pharma ingredient business of Viatris

Multi-sector investment firm IQuest Enterprises will acquire the active pharmaceutical ingredients (API) business of Viatris in India for an undisclosed amount. The investment firm has entered into a definitive agreement to acquire the API operations of global pharmaceutical major Viatris in India, IQuest Enterprises said in a statement on Monday. IQuest emerged as the preferred investor following a global competitive bid, it added. As part of the deal, the company will acquire six API manufacturing facilities, three each in Vizag and Hyderabad, an R&D facility in Hyderabad, and third-party API sales. "We are excited about our largest investment in the pharmaceutical sector till date. Our investment comes at an opportune time when India is drawing significant attention amongst the global pharma industry," IQuest Enterprises Executive Director Gunupati Swathi Reddy noted. IQuest Enterprises is a multi-sector investment company. It has invested in various entities like AIG ...

We approved investment of Rs 6,000 cr under PLI scheme for pharma: Shah

The Centre has approved investment of Rs 6000 crore to 74 industries in the pharmaceutical and medical device manufacturing sectors under the production linked incentive (PLI) scheme, Union Home Minister Amit Shah said here on Saturday. Shah was addressing a gathering after dedicating the newly built campus of the National Institute of Pharmaceutical Education and Research (NIPER) at Gandhinagar. "The Union government has taken a holistic approach and begun the process for the development of a cost-effective, sustainable and affordable process for 16 APIs (active pharmaceutical ingredient) and two KSMs (key starting material)," he said. In the next one decade, India will not just become self-reliant but also be in a position to export them (APIs and KSMs), Shah added. "The Narendra Modi government has given permission for the investment of Rs 4000 crore to about 48 small and big industries in the sector of pharmaceutical manufacturing under the PLI scheme," Shah said. The PLI sche

Advent International announces new board, mgt team of Suven Pharmaceuticals

Global private equity firm Advent International on Friday announced a new board and management of Suven Pharmaceuticals after completing the acquisition of a majority stake in the domestic drug maker. Suven Pharma will be led by a management team comprising Annaswamy Vaidheesh (Executive Chairman), Dr V Prasada Raju (Managing Director) and Dr Sudhir Kumar Singh (Chief Executive Office), Advent International said in a statement filed on BSE by Suven Pharma. In terms of the Board of Directors, along with Vaidheesh and Raju, Pankaj Patwari, Managing Director at Advent, will also join the team, it added. Suven will also have three independent directors - - K.G Ananthakrishnan, Ex-MD MSD India and Ex-Director General of OPPI, and Chairman of PNB; Matangi Gowrishankar, Ex-BP Global Head of Capability Development, and Ex-Director of Human resources, Castrol India, Strategic Advisor and Certified coach; Vinod Rao, former head of investor relations at Diageo and ex-CFO PepsiCo Asia ...

Pharma firm Valiant Lab's IPO subscribed 2.17 times on third day of bidding

The Initial Public Offering (IPO) of pharmaceutical ingredient manufacturing firm Valiant Laboratories was subscribed 2.17 times on the third day of bidding on Friday. The initial share sale received bids for 1,65,77,925 shares against 76,23,030 shares on offer, as per NSE data. The category for Retail Individual Investors (RIIs) was subscribed 3.11 times while the quota for non-institutional investors got subscribed 1.51 times. The portion for Qualified Institutional Buyers (QIBs) received 1.04 times subscription. Price range for the offer is Rs 133-140 a share. The IPO is an entirely fresh issuance of up to 1.08 crore equity shares. Proceeds of the issue will be utilised to set up a manufacturing facility for speciality chemicals in Gujarat through its subsidiary -- Valiant Advanced Sciences Private Ltd -- and to meet the working capital requirements of the subsidiary company. Valiant Laboratories is an active pharmaceutical ingredient or bulk drug manufacturing company with it

Novo Nordisk India head eyes 2026 Wegovy launch, warns against copycats

Wegovy, a weekly injection, is the most effective treatment approved for weight-loss to date at a time when global obesity rates are at a record high

BDR Pharma launches generic drug for fungal infections at 1/3rd the cost

Zisavel capsules will be available as 100 mg capsules and will be priced at Rs 7,992 for 7 capsules

Missouri's CVS pharmacists plan more walkouts over working conditions

After the walkouts began Thursday, the chain dispatched Chief Pharmacy Officer Prem Shah to meet Tuesday with the pharmacists

Govt rolls out Rs 5,000 cr scheme for innovation in pharma, medtech

The PRIP scheme has two main components - the first one would focus on infrastructure building

Pharma sector must focus on innovation to become global leader: Minister

Union health minister Mansukh Mandaviya on Tuesday asked domestic pharmaceutical industry to focus on the research and development of innovative products to move up the value chain and achieve global leadership. Mandaviya, who also holds the Chemical and Fertilisers portfolio, asked medical technology companies to produce critical equipment in India for the global markets. While formally unveiling the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector here, Mandaviya said the domestic pharmaceutical companies invest less on research and development when compared to multinational companies. "International MNCs spend 20-25 per cent of their profits in research and innovation while for Indian companies the average is around 10 per cent...Till the time we do not come out with research-led innovative products, we cannot lead the segment globally," he noted. He said the government wants to make the pharma industry self-reliant by 2047. "Today is a ...

Cough syrup deaths overseas prompts US crackdown on toxic testing

The manufacturers include U.S.-based companies and exporters from India, South Korea, Switzerland, Canada and Egypt

Pharma industry needs to focus on innovative products, says Mandaviya

The domestic pharmaceutical industry needs to focus on the research and development of innovative products in order to move up the value chain and achieve global leadership in the sector, Union minister Mansukh Mandaviya said on Tuesday. The Union health minister, who also helms the Chemical and Fertilisers ministry, asked the medical technology companies to produce critical equipment in India for the global markets. While formally unveiling the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector here, Mandavya said the domestic pharmaceutical companies invest less on research and development when compared to multinational companies. "International MNCs spend 20-25 per cent of their profits in research and innovation while for Indian companies the average is around 10 per cent...Till the time we do not come out with research-led innovative products, we cannot lead the segment globally," he noted. He said the government wants to make the pharma ...

Strides Pharma to spin off CDMO, soft gelatin biz into a new entity

The company's board has approved a scheme of arrangement amongst Strides Pharma Science, Steriscience Specialties and Stelis Biopharma, the drug firm said in a regulatory filing

Abbott India warns of laxatives shortage in tussle with Goa regulator

The two laxative brands together have estimated annual sales of $70 million in India, healthcare data firm Pharmarack says

Biocon Biologics gains EU approval for Aflibercept biosimilar, YESAFILI

According to market research firm IQVIA, Aflibercept generated about $1.8 billion in annual sales in the EU in 2022

Aurobindo's Andhra plant receives 1 observation from USFDA after inspection

Aurobindo Pharma on Wednesday said the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. The US Food and Drug Administration (US FDA) inspected the Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing. At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added. "We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest," Aurobindo Pharma stated. As per the USFDA a 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. Shares of Aurobindo Pharma were trading ...

Govt may soon tweak PLI schemes for pharma, textiles to boost investment

The government may soon tweak the production-linked incentive scheme for pharmaceuticals, drones and textiles sectors to encourage investment and boost manufacturing, an official said. These sectors have been identified after inter-ministerial consultations on the performance of the scheme for various products. The official also said that disbursement of production-linked incentives (PLI) for white goods (AC and LED lights) would start this month and that would push the amount of disbursement, which was only Rs 2,900 crore till March 2023. The scheme was announced in 2021 for 14 sectors such as telecommunications, white goods, textiles, manufacturing of medical devices, automobiles, speciality steel, food products, high-efficiency solar PV modules, advanced chemistry cell battery, drones and pharma with an outlay of Rs 1.97 lakh crore. "We have identified the sectors. We are going to send the combined note to seek approval of the Union Cabinet. The changes include extending some ti