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 […]

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 […]

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 […]

Lupin launches asthma drug in the US

Pharmaceutical major Lupin said it launched the asthma drug Budesonide Inhalation Suspension ampules in the US market.   Budesonide Inhalation Suspension ampules are a generic equivalent of Pulmicort Respules Inhalation Suspension drugs of UK-based pharma firm AstraZeneca. Budesonide Inhalation Suspension ampules had annual sales of approximately USD 385.4 million in the US. Budesonide is used […]

Lupin receives EIR for Pharmacovigilance Inspection from USFDA

Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global  pharmacovigilance group, Drug Safety & Risk Management (DSRM). Pharmacovigilance, also known as drug safety, is the science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with […]

Lupin launches generic epilepsy tablets in the US

Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome. Lennox-Gastaut syndrome (LGS) or childhood epileptic encephalopathy is a pediatric epilepsy syndrome characterized by multiple seizure […]

Lupin to sell Aptissen’s products in Canada

Pharmaceutical major Lupin said it signed a distribution agreement with Switzerland-based pharma firm Aptissen S.A. to exclusively sell Aptissen’s products in Canada. Established in 2013, Aptissen develops hyaluronic acid polymer-based injectable medicinal products in aesthetic medicine, ophthalmology, and orthopedics. It has presence in more than 50 countries worldwide. “This partnership helps us expand our product […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Lupin, YL Biologics get nod to sell rheumatoid arthritis drug in Japan

Pharmaceutical major Lupin said that YL Biologics Limited, its newly formed joint venture with Japanese pharma company Yoshindo Inc has received approval from the Pharmaceutical and Medical Devices Agency (PMDA) for sales of a biosimilar version of Amgen Inc’s Etanercept in Japan. Etanercept, sold under the brand name Enbrel or Benepali. is a biopharmaceutical drug […]

Lupin, Natco get FDA nod to launch generic version of Gleevec cancer drug

Pharmaceutical major Lupin and partner Natco Pharma received approval from the US Food and Drug Administration (FDA) to sell a generic equivalent of Novartis Pharmaceuticals’ Gleevec cancer tablets in the US market. Imatinib Mesylate Tablets, in 100 and 200 mg doses, have annual sales of around $655 million in the United States, Lupin said, making […]

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 […]

US FDA issues observations on Lupin Pithampur plant

Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit. The inspection was conducted between 14th and 25th January said the company. All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant […]