Pharmaceutical major Strides Pharma Science Ltd said it received approval from the United States Food and Administration for its greenfield oral medication facility in Singapore, giving a boost to the company’s efforts to bid for US government contracts. The new unit will help the company supply its products to US government agencies as Singapore is […]
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 Pfizer Inc’s Viagra tablets. Sildenafil tablets is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is taken by mouth or via injection into a vein. Sildenafil […]
Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Sunovion Pharmaceuticals’ Latuda tablets. Lurasidone tablets are used to treat certain conditions associated with bipolar disorder such as schizophrenia and depression. It also helps to decrease hallucinations. The drug will be […]
Pharmaceutical manufacturer Caplin Point Laboratories Ltd said it received approval from the US Food and Drug Administration for sales of a generic equivalent of West-Ward Pharmaceuticals’ Robinul drug. Glycopyrrolate is a synthetic anticholinergic medication which works by blocking acetylcholine activity on smooth muscles and other tissues. Acetylcholine is a neurotransmitter, or a chemical that nerves […]
Gujarat-headquartered Alembic Pharmaceuticals said that it received approval from the United States Food and Drug Administration for sales of a generic version of Mylan’s Optivar eye-drops. Azelastine Hydrochloride Solution eye drops is used to treat itchy eyes caused by allergic conjunctivitis. Azelastine had an estimated US sales of USD 8.5 million for twelve months ending […]
Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the US Food and Administration (USFDA) for the sale of a generic version of Valeant Bermuda’s acne treatment, BenzaClin. Clindamycin and benzoyl peroxide gel is a combination of clindamycin, an antibiotic and benzoyl peroxide, an antiseptic. The gel is mainly used on the skin […]
Pharmaceutical manufacturer Zydus Cadila said it received tentative approval from the US Food and Administration for the sales of of Sitagliptin and Metformin oral diabetes tablets that help control blood sugar levels. Tentative approval implies that the company can launch the product only after the expiry of all patents relating to it. The combination drug, […]
Pharmaceutical company Unichem Laboratories said it received final approval from the United States Food and Drug Administration for the sale of a generic version of Casper Pharma’s Zyloprim tablets. Allopurinol is a medication used to decrease high uric acid levels. It is specifically used to prevent gout and specific types of kidney stones. Taken by […]
Pharmaceutical manufacturer Zydus Cadila said it received final approval from the US Food and Drug Administration for the sales of Potassium Chloride extended-release tablets for the treatment of various diseases such as prolonged diarrhoea and vomiting, hormone problems such as hyperaldosteronism and diuresis. The tablet, sold under the brand names Klor-Con, K-Dur and Micro-K, is […]
Pharmaceutical manufacturer Zydus Cadila said it received final approval from the US Food and Drug Administration to launch Atenolol and Chlorthalidone tablets to treat hypertension and chest pain. The company did not reveal the market size of the drug. Atenolol, sold under the brand name Tenormin, is a beta blocker medication used to treat high […]
Pharmaceutical manufacturer Laurus labs said it received final approval from the US Food and Drug Administration to launch a generic equivalent of Concordia Pharmaceuticals’ malaria drug Plaquenil. Hydroxychloroquine is also used for treating diseases like rheumatoid arthritis and lupus and is sold under the brand name Axemal in India. The company also received a tentative […]
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 […]
Strides Pharma said the US Food & Drug Administration completed an inspection of the company’s primary manufacturing facility in India with zero adverse observations. The company’s formulations facility at KRSG Gardens in Bangalore was inspected by the USFDA for good manufacturing practices in August 2018 and November 2018. Strides Pharma said it received the Establishment […]
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 […]
Indian pharmaceuticals manufacturer Wockhardt said it received approval from the United States Food & Drug Administration to launch a generic version of Novartis’ Leukemia drug Gleevec. The drug is estimated to have sales of $707 million in the US. The Indian company, which already has many of its products on US pharmacy shelves, said it […]
India-based pharmaceuticals manufacturer Lupin said it received approval from the US FDA to sell a generic equivalent of Latuda tablets for treating bipolar disorder and schizophrenia in adults. Latuda, a product of Sunovion Pharmaceuticals, has sales of over $3.2 billion in the US alone, making it one of the bigger drugs in the market. Permission […]
Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US for the three dosages for which approval has been received […]
Pharma major Lupin said the US Food & Drug Administration has given it an Establishment Inspection Report for its Tarapur facility. The company had two months ago pointed out that the inspection, carried out in August, had been completed with one observation related to what it called a “procedural deficiency”. The receipt of an EIR is […]
Pharmaceutical manufacturer Lupin said it received approval from the US FDA for launching Decitabine injection for treating conditions caused by defective blood cells, known as myelodysplastic syndromes. Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately USD 135.9 million in the US. The drug is the generic equivalent of Otsuka Pharmaceutical Co. Ltd.’s […]
Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, with annual sales of around $475 million. It is sold by AstraZeneca under the name Pulmicort Respules Inhalation Suspension. The drug is indicated for the […]
