Search Result for : Usfda

The Dollar Business Bureau  Drug making company Zydus Cadila said on Wednesday that it has got approval from the United States health regulator to sell methotrexate tablets, a drug used in chemotherapy, in the US market.  “The company has received final approval from the US Food and Drug Administration (USFDA) to market the drug,” Zydus Cadila said in a filing with BSE. The drug will be produced at the company’s manufacturing unit in Ahmedabad, Gujarat.  The Gujarat-based company now has over 105 approvals and till now has filed around 275 ANDAs (abbreviated new drug applications) since 2003-04.  Cadila Healthcare Limited is a leading global pharma company, and its arm Zydus Pharmaceuticals Inc. is a leading generic pharma company in the US. Zydus Cadila ...

The Dollar Business Bureau The US Food and Drug Administration (USFDA) has restricted imports of drugs from Pune-based Badrivishal Chemicals & Pharmaceuticals. The US drug regulator has issued the alert under Import Alert 66-40, which authorises the health regulator "detention without physical examination of drugs from firms which have not met drug GMPs". The company manufactures active pharmaceutical ingredients and specialty chemicals and exports its drugs to more than 30 countries including US, UK, Germany and France. Badrivishal Chemicals & Pharmaceuticals’s Pune-based plant is approved by Maharashtra FDA and is spread across an area of over 12,000 square feet. Another Indian drug major, Zydus Discovery, a research subsidiary of Cadila Healthcare, has also been pulled up by the USFDA for misbranding Saroglitazar, a drug used to treat ...

The Dollar Business Bureau Mumbai-based pharmaceutical company Sun Pharma has acquired a branded oncology product, Odomzo (sonidegib), from Novartis after making an upfront payment of $175 million (about Rs 1180 crore) and some additional milestone payments. The deal has been fixed between subsidiaries of both the companies and will be finalised after putting in place some anti-trust clearance and further closing conditions.  Odomzo is a hedgehog pathway inhibitor which was approved by the US FDA in July 2015. It has been indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. The prescription of these drugs is made by around ...

The Dollar Business Bureau  Indian pharmaceutical company, Strides Shasun Ltd, has acquired Perrigo's active pharmaceutical ingredients (APIs) manufacturing facility, based in Ambernath city of Maharashtra for Rs.100 crore.  “The company has inked a definitive agreement to acquire the complete shareholding in Perrigo API India Pvt Ltd for Rs.100 crores,” Strides Shasun said in a press release.  The deal is likely to be completed by December 31, 2016, it said.  Commenting on the deal, Shashank Sinha, Group CEO, Strides Shasun, said, “This acquisition will bring a manufacturing facility into the company’s fold which is designed to manage multi-purpose small batch productions and speed up our time to the market.”  “This goes well with the Strides' strategy of creating a backward integrated portfolio of small volume and niche ...

The Dollar Business Bureau Alembic Pharmaceuticals, a leading pharma company in India, has received the US Food and Drug Administration (USFDA) nod for selling Zolmitriptan Orally Disintegrating tablets in the US market. These medicines are used in the treatment of migraine. “The company has received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5 mg,” Alembic Pharmaceuticals said in a filing to BSE. The drug is a therapeutic equivalent to Zolmig-ZMT Orally Disintegrating tablets, the reference listed drug product (RLD) of the company AstraZeneca Pharmaceutical in the same strengths, the release added. These Zolmitriptan tablets are used for acute treatment of migraines in adults, the company said. Currently, the company has approvals for 51 ANDA from USFDA, ...

The Dollar Business Bureau Aurobindo Pharma on Monday announced that it has received the go-ahead from the US-based health regulator USFDA to manufacture and market its anti-infective Linezolid injection in the American market.  "The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Linezolid injection, 600 mg/300 mL (2 mg/mL)," Aurobindo Pharma said in a statement. The company plans to launch the product during the second quarter of the current financial year. It has the generic version of Pharmacia & Upjohn Company's Zyvox injection in the same strength.   "The approved product has an estimated market size of $87 million for the twelve months ending June 2016 according to IMS," it said. This latest approval is Aurobindo Pharma’s 36th abbreviated new drug ...

PTI Natco Pharma Ltd today said it has received final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules (Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg, from the US Food and Drug Administration. “Natco and its marketing partner Alvogen are the first generic players to receive this approval,” Natco said in a regulatory filing. Tamiflu is used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than two days. Tamiflu can also reduce the chance of getting the flu in people one year and older. Earlier in December, 2015, Natco and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. ...

The Dollar Business Bureau Sanofi-Synthelabo (India) Private Limited, Mumbai, a division of Sanofi announced the launch of two drugs Lyxumia and Zemiglo for type 2 diabetes patients in India. Lyxumia a non-insulin injectable drug, is prescribed once daily and Zemiglo, an oral tablet is prescribed to be taken once in a day. India is home to second largest number of diabetics after China in the world. The International Diabetes Federation Diabetes Atlas 2015, says India has 69.1 million diabetic patients which is expected to rise to 140 million in 2040. And 1 million deaths in India occur only due to diabetes. These alarming statistics reveal the diabetic epidemic that India is undergoing right now. Counter measures in the form of diet, exercise and ...