Search Result for : Fda

The Dollar Business Bureau Lupin Limited (Lupin), a transnational pharma company, announced on Wednesday that its US-based subsidiary Lupin Pharmaceuticals, Inc (LPI) has got the final approval from FDA for its Armodafinil Tablets, used in treatment of obstructive sleep apnea. “Company’s US subsidiary Lupin Pharmaceuticals, Inc has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg,” Lupin said in a release. LPI shall start promoting the products in the US market shortly, it added. The pharma major’s Armodafinil tablets in 250 mg, 200 mg, 150 mg and 50 mg are ...

The Dollar Business Bureau The consumer products division of Piramal Enterprises has acquired four brands from Pfizer for Rs.110 crore, namely Ferradol, Neko, Sloan’s and Waterbury’s Compound. The agreement contains the trademark rights for Ferradol and Waterbury’s Compound in Bangladesh and Sri Lanka, the company said in a statement on Friday. The finalisation of the deal is subjected to approval from regulatory authority. Nandini Piramal, Executive Director, Piramal Enterprises said, “Our main aim is to become a prominent player in every business under the healthcare segment of Piramal Enterprises Ltd. “Piramal is one of the largest companies in custom manufacturing and has manufacturing units in Asia, European Union and North America. Our Critical Care vertical is the third largest in ...

Jayarama Emani | The Dollar Business “India is quickly becoming a significant player in the global marketplace, representing an important source of FDAregulated products. With a diverse population, highly skilled work force, and favourable economic conditions, India has become an increasingly attractive location for companies to operate,” said the United States Food and Drugs Administration (USFDA) in its blog FDA Voice. “Each year, the FDA has to assess millions of products grown, harvested, processed, manufactured and shipped from outside of the U.S. And one of the most impressive examples of how this globalization of production, consumption and trade has altered the regulatory landscape is India,” said the blog. The blog went on to add that Indian regulators have become ...

Sai Nikesh | The Dollar Business  In a move to boost pharmaceutical industry, the Government of India is working towards the promotion of exports, especially by the micro and small enterprises of the pharma sector. This was informed by the Union Commerce Minister, Nirmala Sitharaman on Wednesday. The Union Minister informed that the Central Drugs Standard Control Organization (CDSCO) was unaware of the fact that majority of small pharma manufacturers are working for bigger pharmaceutical units which export the same under their brand name. In this regard, the government has taken various measures to promote exports by small and medium pharmaceutical manufacturers, which includes financial assistance through Pharmaceuticals Export Promotion Council of India (Pharmexcil), she added. Under the Market Development Assistance ...