Glenmark, Cipla get US nod for inhaler drug

Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]

Lupin gets US FDA warning letter for Somerset plant

Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]

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 […]

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 […]