ICMR to start BCG Vaccine study for Coronavirus next week

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 […]

Biocon gets Form 483 observations for API plant

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 gets two observations for Karkhadi plant

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 […]

Natco Pharma seeks nod for generic copy of Taiho’s cancer drug Lonsurf

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 gets US FDA warning letter for Moraiya facility

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 Pharma launches dry-eye treatment in the US

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 […]

Morepen Labs readies multi-billion APIs for manufacturing from Dec

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 […]

Lupin appoints Apotex veteran as new head of quality

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 Pharma licenses two products to China Medical System

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 […]

Indoco Remedies’ Goa facility receives four observations from USFDA

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 […]

Suven Life Sciences gets patents for neurodegenerative disease candidates

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 […]

Laurus Labs partners UN organisation for sales of HIV/AIDS pills

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 […]

Lupin gets nod to sell generic form of Viagra in the US

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 […]

Zydus Cadila gets USFDA nod for generic Zovirax ointment for herpes

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 […]

Piramal launches generic equivalent of Amgen’s Sensipar tabs in US

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 […]

Laurus Labs gets USFDA nod for malaria drug

Pharmaceutical manufacturer Laurus labs said it received final approval from the US Food and Drug Administration to launch a generic equivalent of Concordia Pharmaceuticals’ malaria drug Plaquenil. Hydroxychloroquine is also used for treating diseases like rheumatoid arthritis and lupus and is sold under the brand name Axemal in India. The company also received a tentative […]

Glenmark reports progress in its eczema drug investigation

Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema. The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug […]

Lupin launches exclusive generic version of Ranexa heart drug in US

Pharmaceuticals manufacturer Lupin said it has launched an exclusive generic version of Gilead Sciences’ heart drug Ranexa in the US. Ranolazine ER, to be sold in 500mg and 1000mg tablets, is indicated for the treatment of chronic angina or chest pain. “Products like Ranolazine bring significant savings to US consumers and are a key part […]