Indian pharmaceuticals manufacturer Lupin Ltd said it received a non-exclusive license to manufacture the anti-TB drug pretomanid from non-profit drug developer, TB Alliance. The company said it plans to sell the drug in 140 countries and territories, including many of the highest TB burden countries around the world. Pretomanid will be administered as part of […]
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 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 […]
Glenmark Pharmaceuticals Ltd said it has launched a new diabetes drug in India at a price that is around 65% cheaper than those of competing offerings. The new drug is a combination of a Sodium Glucose Co-Transporter Inhibitor (SGLT2i) and a Dipeptidyl Peptidase 4 inhibitor. “Glenmark’s Remo V and Remozen V are priced at Rs. […]
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 […]
Pharma major Lupin Limited (Lupin) said it has received tentative approval from US FDA for Empagliflozin and Linagliptin tablets used to control blood sugar levels. The approval is for selling combinations of 10 mg+5 mg and 25 mg+5 mg of the drugs. In these dosages, the tablets have annual sales of around 242 million in […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Pharmaceutical major Lupin said that it received tentative approval from the United States Food and Drug Administration for the sales of a generic equivalent of Merck Sharp & Dohme Corp’s Emend Injection drug. Fosaprepitant, 150 mg had annual sales of $312 million in the US market. A tentative approval means that the company has to […]
Pharmaceutical major Lupin said that it has launched a generic equivalent of AbbVie Inc’s AndroGel, a a day after it received approval for its sales from the United States Food and Drug Administration (USFDA). Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed […]
Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of AbbVie Inc’s AndroGel. Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed through the skin, enters the bloodstream, […]
Pharmaceutical major Lupin said that it launched a generic equivalent of Alvogen Group Holdings’ psychiatric drug Fluoxetine. Fluoxetine tablets sold in 60 mg dose had annual sales of $41 million in the US market as of February 2019. Fluoxetine is also sold under the brand name Prozac as a treatment for depression and other mental […]
Pharma major Lupin said that the inspection of the US Food and Drug Administration (USFDA) at its bioresearch facility in Pune has concluded without any observation. Conclusion of an inspection without any observation indicates that the facility was found to be up to the standards expected by the FDA. This is also the fifth time […]
Pharma major Lupin said that the United States Food and Drug Administration has given it an Establishment Inspection Report (EIR) for its Pithampur facility, which was slapped with five observations in an inspection in October. The receipt of an EIR is considered good news as it means that the company can now use the facility […]
Pharmaceutical major Lupin said that it has launched the generic equivalent of Eli Lilly’s Cialis erectile dysfunction tablets. Lupin had received the approval from the United States Food and Drug Administration to sell the tablets along with its rivals Zydus Cadila, Unichem Laboratories and Alembic Pharmaceuticals on March 27. Tadalafil tablets are used to treat […]
