Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US. It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged […]
Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident. The inspection, carried out in September, was related to the manufacture of Phenytoin Sodium Extended Release capsules to be sold in the US market. Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage […]
Glenmark Pharmaceuticals said has got final approval from the United States Food & Drug Administration to launch generic version of Derma-Smoothe scalp oil of Hill Dermaceuticals. The drug is among the smaller ones by sales and had 12 month sales of just around $14.0 million in the US. With this, said Glenmark, its current portfolio […]
Alembic Pharmaceuticals said one of its dermatology-focused joint ventures cleared its first United States Food and Drugs Administration (USFDA) inspection at its new formulation manufacturing facility located at Karakhadi, Gujarat, India without any observations. The inspection was carried out between 15th October, 2018 and 19th October, 2018. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical […]
Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep 17 – 21, 2018. “The week-long audit concluded without any observations and no […]
Pharma major Lupin said the inspection of the US Food and Drug Administration at its Nagpur plant has “concluded without any observation.” Conclusion of an inspection without any observations indicates that the facility was found to be up to the standards expected by the FDA. This inspection was a product specific pre-approval inspection, it said. […]
Sun Pharmaceutical Industries said it has got US Food and Drug Administration approval for a new eye drug that will be used for lowering intraocular pressure or IOP in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma Advanced Research Co (SPARC), and was licensed by Sun Pharma, […]
Zydus Cadila said it received the final approval from the USFDA to market cholesterol-lowering Gemfibrozil and antipsychotic Aripiprazole in the US. Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. It is also used to lower the risk of stroke, heart attack or other heart […]
Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution. Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes. The solution, with an estimated US market size of $63 million, increases the length, thickness and darkness […]
Zydus Cadila said it received the final approval from the USFDA to sell Spironolactone Tablets, used to treat blood pressure and heart failure. The tablets, in strengths of 25 mg, 50 mg and 100 mg, will be used for lowering high blood pressure to prevent strokes, heart attacks and kidney problems. It is also used […]
Glenmark Pharmaceuticals said received approval from the United States Food & Drug Administration to sell cholesterol-lowering drug Colesevelam Hydrochloride in the country. The approval is for two packet sizes – 1.875 grams and 3.75 grams. Colesevelam Hydrochloride is the generic version of Daiichi Sankyo’s oral suspension Welchol. Welchol had annual sales of approximately $73.0 million for […]
Zydus Cadila said it has received tentative regulatory approval from the US Food & Drug Administration for selling Deferasirox, used to chelate or expel excess iron from the blood. The drug is sold under names such as Exjade, Desirox, Defrijet, Desifer, Rasiroxpine and Jadenu. Tentative approval means that the company has to wait for all […]
Glenmark Pharmaceuticals received a boost for its plans to manufacture drugs within the US, with the FDA approving the first generic manufacturing application from the facility. The FDA approved the manufacturing of Atovaquone and Proguanil Hydrochloride Tablets at its Monroe, North Carolina facility via a supplementary ANDA (drug application). “This approval is an important milestone for our […]
Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million in 2017, according to IQVIA. It is sold by Pfizer under thebrand Vibramycin. […]
Pharma giant Zydus Cadila said it received final approval from the US Food and Drug Administration to sell a skin ointment and an ulcer tablet in the country. Ointment Nystatin is used to treat fungal skin infections and will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. Capsule Omeprazoleand Sodium Bicarbonate is used […]
The United States Food & Drugs Administration has closed its audit of the UK manufacturing plant of Dr Reddy’s Laboratories, the Indian pharmaceutical company said. In September last year, the company had announced that the US FDA issued a Form 483 with three observations regarding operations at the pharmaceutical drug manufacturing plant at Mirfield, leading […]
Pharmaceuticals maker Zydus Cadila said it received the final approval from the USFDA to market inflammation solution Diclofenac Sodium in the country. Diclofenac Sodium topical solution, 1.5%, is a non-steroidal anti-inflammatory drug (NSAID) used for symptomatic treatment of osteoarthritis of the knee. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, the […]
India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln. AbbVie, which has patents valid up to 2020 on the […]
Pharma manufacturer Strides Shasun said it received approval from the United States Food and Drug Administration to sell a generic version of Merck’s Periactin tablets. The US market for Cyproheptadine Hydrochloride Tablets is approximately USD 20 Million, according to IQVIA, the company said. The drug is an antihistamine used to relieve allergy symptoms such as […]
Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat. Form 483 is issued to firm management at the conclusion of an inspection when an investigators observes conditions that in their […]
