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 […]
Alembic Pharmaceuticals said it has received US FDA nod to sell three generic drugs and formulations in the US with a combined annual market size of over $600 million in the country. All three are based on the core ingredient Deferasirox, which is used to treat chronic drug overload due to blood transfusions in patients […]
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 […]
Directors of diagnostic chain Thyrocare today said no to founder and chairman Arokiaswamy Velumani’s offer to buy out its latest venture aimed at democratising access to cancer diagnostic services. At present, cancer screening and diagnostic services are extremely expensive, and Velumani — the son of a landless farmer — has been working for some time […]
Pharma major Lupin said it has agreed to sell its Japanese injectables business to a wholly owned subsidiary of Neopharma group, the UAE’s largest pharmaceutical manufacturer headquartered in Abu Dhabi. Lupin has agreed to sell all the issued and outstanding share capital in its unit Kyowa Criticare Co. Ltd to neo ALA Co. Ltd, a […]
Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]
Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection. The receipt of an EIR signifies the successful closing of the inspection as far as the company is concerned. Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral […]
Caplin Point Laboratories said it has received an Establishment Inspection Report (EIR) from the US FDA for a recently concluded inspection at the manufacturing plan run by its unit Caplin Steriles Limited. “This was the third successful US FDA audit at the plant since 2016,” the company said, referring to the June inspection. An EIR […]
Bharatiya Janaushadhi Pariyojana (BJP) will increase the number of medicines supplied via its outlets to 738 in the next two months, minister Sadananda Gowda said. At present, the scheme has only been able to source and supply only 713 medicines out of a targeted 900 due to a lack of interest among suppliers. Bharatiya Janaushadhi […]
Union Health Ministry today announced that 18 out of 141 bats that were tested for Nipah Virus following last months’ outbreak in Kerala tested positive for the presence of Nipah virus as well as for relevant antibodies. About ten days ago, the ministry had said that the National Institute of Virology at Pune had found […]
Maharashtra, Madhya Pradesh and Chhattisgarh have the dubious distinction of being the worst states for H1N1 patients in India. Not only do they have relatively high number of patients, but your chances of making it alive as an H1N1 patient are also the lowest in India in these states. Other states — Gujarat, Rajasthan and […]
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 […]
India’s Glenmark Pharmaceuticals Ltd said it entered into an exclusive marketing agreement with Novartis Biosciences S.A, a subsidiary of Novartis AG, for three products meant for treating chronic obstructive pulmonary disease (COPD) in Brazil. Under the terms of the agreement, Novartis remains the holder of the registration of these medicines and will be responsible to […]
Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin. According to IQVIATM sales data, the EVOCLIN Foam 1% has sales of $17.0 million per year in the US. EVOCLIN Foam is indicated for topical application in the treatment of […]
HDFC said it has agreed to buy a 51% of Apollo Munich Health Insurance Company Ltd for around Rs 1,347 cr. Apollo Munich will be merged with HDFC’s general insurance subsidiary, HDFC ERGO General Insurance Company Limited, even as Munich Re continues to remain invested in the new, merged entity. HDFC already has a joint […]
Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process inspection was done between June 6th and 14th. “The Company believes these to be of procedural in nature and the corrective and preventive actions for […]
Diversified group Piramal Enterprises Ltd said it has sold its entire direct stake of 9.96% in Shriram Transport Finance Co Ltd via the stock exchanges. The move comes at a time when non-banking finance companies find the going tough due to a slow down in credit flow to the industry. The company did not reveal […]
