The partnership with Cuban-backed Cost Plus Drugs is expected to bolster Lupin's U.S. business, which already accounts for nearly 33% of its 2023 revenue
Biocon on Wednesday said its arm Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America with effect from September 1, 2023. Since the acquisition agreement closed in November 2022, Biocon Biologics has executed a robust integration plan to ensure a seamless transition of partners, people, systems, and processes, Biocon said in a regulatory filing. In February 2022, Biocon Biologics had inked a pact to acquire Viatris Inc's biosimilars business for a consideration of up to USD 3.33 billion (about Rs 24,990 crore). Later, in November same year the company completed the acquisition. "Our successful North America (US and Canada) transition marks the second wave of our integration of the Viatris biosimilars' business, quickly following Emerging Markets and ahead of schedule," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said the company would be leading the commercial operations in the US and Canada
According to the health ministry, this is being done to stop the misuse and illicit trade of these drugs
NPPA permits 12.1% increase for NLEM drugs in 2023
Roche Pharma India launched an industry-first customer experience center to spur collaboration with healthcare professionals, researchers and educational institutions to shape the future of healthcare, the company said on Thursday. The center will offer immersive and interactive healthcare content, comprehensive insights into medical science and information about Roche's innovative, life-changing product portfolio and technologies that have redefined healthcare for over 125 years, the wholly owned subsidiary of the Basel-headquartered Roche Group, said. Doctors and other stakeholders will be able to visualise disease pathways, drug-action in the human body, and co-create better solutions leading to better patient outcomes by using the latest 4IR (Fourth Industrial Revolution) digital technologies such as Augmented Reality (AR), Virtual Reality (VR) and AI, a release here said. "The Roche Experience Center reflects the company's mission to empower communities with scientific insights
The US health regulator has granted Voluntary Action Indicated classification to Torrent Pharmaceutical's manufacturing site in Dahej, Gujarat. A VAI classification means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action. As per the information available on its website, the United States Food and Drug Administration (USFDA) has granted Voluntary Action Indicated (VAI) classification to the plant. The Dahej site was earlier placed under 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome. OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The Dahej site was re-inspected by the USFDA between May 17 and May 25, 2023 and the officials had issued Form 483 with two observations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has ..
The pharmaceutical industry has also aired concerns about quality if only generic names are penned in prescriptions
Govt rolls out research-linked incentive scheme to boost infra
Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Metoprolol Succinate extended-release tablets used for lowering blood pressure. The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application is for Metoprolol Succinate extended-release tablets of strengths 25 mg, 50 mg, 100 mg, and 200 mg, Lupin said in a regulatory filing. These are generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC. This product will be manufactured at Lupin's Pithampur facility in India, the company said. Metoprolol Succinate extended-release tablets had an estimated annual sales of USD 305 million in the US, the company said citing IQVIA MAT June 2023 data.
India is the world's largest producer and exporter of generic drugs. But how did it manage to do so? Let us find out here
The Indian Medical Association (IMA) on Monday demanded deferring the implementation of the National Medical Commission regulations that make it mandatory for doctors to prescribe generic drugs, stating the biggest impediment to such medicines is the uncertainty about their quality. The IMA stated that less than 0.1 per cent of the drugs manufactured in India are tested for quality. "This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are not negotiable," the association said in a statement. The National Medical Commission (NMC) in its "regulations relating to professional conduct of registered medical practitioners" stated that all doctors must prescribe generic drugs, failing which they will be penalised and even their licence to practise may be suspended for a period. It also asked doctors to avoid prescribing branded generic drugs. Rather than taking the NMC route the government should take
"Power thus shifts to chemists instead of doctors. Whichever company offers better incentives, the chemist would prefer it," the industry feared
Industry insiders feel this is a step towards implementing and codifying the Uniform Code of Pharmaceutical Marketing Practices
India has started manufacturing 38 active pharmaceutical ingredients, or APIs, in the last one and a half years on which it was import-dependent, under the production-linked incentive (PLI) scheme for the sector, Union Health Minister Mansukh Mandaviya said here Saturday. Mandaviya said that the 2017 border standoff with China at Doklam triggered India to rethink its self-reliant strategy regarding active pharma components as it was dependent on just one country for the import of 95 per cent of APIs for the formulation industry. The health minister was speaking at the inaugural event of the Healthcare Summit organised at the Indian Institute of Management Ahmedabad (IIMA). Through the PLI scheme, we tried to ensure that the country does not have to import 54 APIs from abroad and our formulation industry gets APIs domestically. I am happy to share that in just a year and a half, India has started manufacturing 38 APIs, which is an example of Atmanirbhar Bharat, he said. The governme
Indian drugs regulators have taken action against 105 pharmaceutical companies after a risk-based inspection and audit of manufacturing plants, the health minister said on Tuesday
Pharm index has broken out on upside, with the positive rally anticipated to hit 14,450
If drug manufacturers are found flouting the ceiling, they will have to deposit the overcharged amount with the Centre
The pharma company published the results of phase two of the clinical trial of Retatrutide, showing impressive weight loss and regulation of blood sugar levels in undertrials
Drug firm Boehringer Ingelheim on Monday said it has appointed Gagandeep Singh as head of the pharma business vertical for the Indian market. The company has appointed Singh as Managing Director and Head of Human Pharma India with effect from July 10. He will also join the Board of Boehringer Ingelheim India, the company said in a statement. Boehringer Ingelheim has three business areas -- Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. "Gagandeep's passion for fostering a customer-focused culture and his experience across complex health ecosystems will be invaluable to the organisation as we continue to strengthen our strategic and sustainability commitment to India," Boehringer Ingelheim Regional Managing Director and Head of Human Pharma for India, Middle East, Turkey and Africa Mohammed Tawil noted. Singh joins Boehringer Ingelheim from AstraZeneca, where he was the Managing Director for India and Africa Cluster Head. He succeeds Vani Manja, who mov
Mandaviya says joint squads of state and Centre formed for risk-based assessment of plants