Mumbai-based pharmaceuticals manufacturer Vaishali Pharma said it has entered the US market by launching its orthopaedic belts and similar products. The company is among the smaller sized pharmaceutical manufacturers in India, with annual sales in the range of around Rs 40 cr. Established in 1989, it manufactures and supplies bulk drugs, pharmaceutical ingredients, formulations, surgical […]
Pharma major Lupin Limited (Lupin) said it has received tentative approval from US FDA for Empagliflozin and Linagliptin tablets used to control blood sugar levels. The approval is for selling combinations of 10 mg+5 mg and 25 mg+5 mg of the drugs. In these dosages, the tablets have annual sales of around 242 million in […]
Glenmark Pharmaceuticals Ltd said its trial of Favirpiravir showed a 28.6% faster recovery among those treated with the antiviral drug than on those who were on standard therapy. The 150-person trial showed “numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until […]
Dr. Reddy’s Laboratories, one of India’s biggest pharmaceuticals manufacturers, said it has signed a licensing agreement with Japan-based FUJIFILM to manufacture anti-viral drug favipiravir. Favipiravir is traditionally used to treat infuenza, and is also being tested in COVID-19 patients. Dr Reddy’s said the tie-up is part of the Japanese company’s efforts to ramp up the […]
Indian Council of Medical Research, India’s top body for the formulation, coordination and promotion of biomedical research, said it will start a new trial next week to study the efficacy of anti-TB vaccine BCG in preventing mortality in COVID-19. The statement comes even as the World Health Organization has said that there is no evidence […]
Aurobindo Pharma Ltd has said that the US FDA has lined up one of its oral solids formulation plants in Telangana for regulatory action, following adverse findings in an October inspection. The company’s shares had fallen by 19% in intra-day trading on October 8, soon after the company disclosed that FDA inspectors had made seven […]
The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]
Alembic Pharmaceuticals, one of India’s biggest drug makers, received two observations from US FDA officials who inspected its plant at Karkhadi in Gujarat. Observations, given in Form 483, indicate that the inspectors were not fully satisfied with what they found during the visit. In a Form 483, the FDA typically outlines conditions or practices at […]
India-based Natco Pharma has filed an application with the US Food and Drug Administration seeking permission to market a generic copy of Lonsurf, a drug approved just four years ago to treat colorectal/gastric cancers. The application has been filed with a ‘Paragraph IV’ declaration. Such a declaration essentially states that the filer, Natco, believes that […]
Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]
Sun Pharmaceutical Industries Ltd said one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S. CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory […]
Pharmaceuticals manufacturer Morepen Laboratories Ltd said it is ready to start manufacturing and selling three multi-billion dollar drugs, two of which are set to go off-patent in December this year. The current global market size for Rivaroxaban, a powerful anticoagulant (blood thinner), is $7.19 billion (Rs. 51,000 cores). It is the 10th largest selling drug […]
Pharmaceuticals maker Lupin has appointed a new head of quality for the company, as it strives to remain compliant with international safety and manufacturing norms throughout its vast manufacturing base across the world. Johnny Mikell, the new global head of quality, comes from a similar role at Canada-based pharmaceutical manufacturer Apotex, and has 35 years […]
Sun Pharmaceutical Industries today announced that it had licensed two of its products — for psoriasis and for dry eye — to China Medical System Holdings Ltd or CMS. CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the Indian pharma company said. The financial […]
Mumbai-based pharmaceutical company Indoco Remedies said that the United States Food and Drug Administration (USFDA) issued four observations after its inspection at Indoco’s sterile manufacturing facility in Verna, Goa. The facility at Verna mainly manufactures ophthalmics and injectables for ophthalmic preparations. Apart from USFDA, the facility has also been approved by the Medicines Control Council […]
Pharmaceutical company Suven Life Sciences said it has been granted product patents for a new compound being developed for the treatment of neurodegenerative diseases in Eurasia, Europe, South Korea and Sri Lanka. The compounds are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like the […]
Pharmaceutical manufacturer Laurus Labs said that its has entered into a strategic partnership agreement with United Nations’ The Global Fund to sell a generic version of Viiv Healthcare’s dolutegravir (DTG) tablets in the Sub-Saharan countries for three years. Tenofovir/Lamivudine/Dolutegravir (TLD) is a combination drug used for the treatment of HIV/AIDS. Laurus had previously received approval […]
Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Pfizer Inc’s Viagra tablets. Sildenafil tablets is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is taken by mouth or via injection into a vein. Sildenafil […]
Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration for the sale of a generic version of Valeant’s Zovirax ointment. Acyclovir, belonging to a class of medications called antivirals, is used to treat cold sores or fever blisters caused by herpes viruses. The ointment will be […]
Even as US-based Amgen Inc mounts a legal challenge, Piramal Enterprises said its US partner Slate Run Pharmaceuticals has launched the generic equivalent of Amgen’s hyperthyroidism drug Sensipar. Amgen challenged Piramal’s license to manufacture a bio-equivalent version of the drug soon after the Indian company got the regulatory nod in August last year. However, Piramal […]
