Gufic Lifesciences gets nod for injectables unit merger

Gufic Lifesciences Ltd, one of the oldest pharma companies in India, today said it has won the last pending regulatory approval for the amalgamation of its injectables unit with itself. It said it won approval from National Company Law Tribunal Mumbai for the merger last week. Since the transaction has a date of Jan 1, […]

Biocon, Lupin launch new drugs in USA

Bicon Ltd and Lupin Ltd, two India-based pharmaceutical manufacturers, launched two drugs in the US, separately. Bangalore-based Biocon launched an immunosuppressant, while Lupin launched a pain relief drug. Biocon’s drug is called Tacrolimus, and it is a calcineurin inhibitor. The company said the drug is used in organ transplant patients to reduce the body’s ability […]

Indoco Remedies wins big order from Germany for uric acid tablets

Pharmaceuticals manufacturer Indoco Remedies has won a major contract to supply Allopurinol, used to bring down uric acid in the blood, from Germany. The two-year contract will generate around Rs 70 cr per year for the company. “This is Indoco’s first own label product in Europe,” said Managing Director Aditi Kare Panandikar. “Germany is totally […]

Zydus’ cytokine inhibitor moves into clinical trial

Pharmaceutical manufacturer Zydus Cadila said it received permission to initiate clinical trials for ZYIL1, an oral small molecule NLRP3 inhibitor, as an anti-inflammatory agent. The molecule is being explored for treating a variety of inflammation-related conditions, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, gastro-intestinal diseases (inflammatory bowel disease), […]

Laurus Labs buys Bangalore-based biotech firm Richcore for Rs 247 cr

Indian drugmaker Laurus Labs said it signed a definitive agreement to acquire a majority stake in a Bangalore-based, fast-growing biotech company, Richcore Lifesciences, for Rs 246.67 cr. Richcore has advanced R&D and manufacturing facilities to develop and manufacture biotech products critical for manufacturing biological drugs. Richcore also helps its global customers to develop and scale-up […]

Vaishali Pharma enters US market

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 […]

Glenmark says Favipiravir trial shows 29% faster recovery in COVID-19

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 […]

COVID-19: Dr Reddy’s signs deal to make and sell favipiravir globally

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 […]

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 […]