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 […]

Thyrocare board says no to founder Velumani’s offer to buy scanning arm

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 […]

Lupin sells Japanese injectables business to UAE-based Neopharma

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 Moraiya plant could face FDA action

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 […]

Lupin’s Aurangabad plant passes USFDA inspection

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 Labs Chennai plant passes USFDA checks

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 […]

MP, Maharashtra worst at managing H1N1 in India

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 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 […]

Glenmark to distribute Novartis drug in Brazil

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 gets tentative US approval for Mylan’s acne cream

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 to acquire majority stake in Apollo Munich at Rs 1,347 cr

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 […]

Caplin Point Labs gets 2 observations from US FDA for Chennai plant

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 […]

Piramal Enterprises sells 10% stake in Shriram Transport Finance

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 […]

Dr Reddy’s sells two neurology products to Upsher-Smith Laboratories

Hyderabad-headquartered pharmaceutical firm Dr Reddy’s Laboratories said that it will sell two of its branded neurology products to US-based pharmaceutical company Upsher-Smith Laboratories. Dr Reddy’s will sell its US and select territory rights for  Zembrace Symtouch injection and Tosymra nasal spray to Upsher-Smith. Both drugs are sold through Dr Reddy’s wholly-owned subsidiary, Promius Pharma. Zembrace […]

Natco Pharma’s Kothur facility receives 9 observations from USFDA

Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco’s formulation facility in Kothur, Hyderabad. Natco said it believes that most of the observations were ‘procedural’ in nature and not pertaining to data integrity. Natco said that it will address the USFDA observation within […]

Alembic Pharmaceuticals gets USFDA nod for Parkinson’s drug

Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme Corp’s Sinemet Carbidopa/Levodopa sustained release tablets in the US market. Carbidopa and Levodopa Extended-Release tablets are used to treat symptoms of Parkinson’s disease and Parkinson’s-like […]