Alembic Pharma gets FDA approval for Zolmitriptan tablets
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, ...
Govt clears four new FDI proposals worth Rs.385 crore
The Dollar Business Bureau The government on Monday gave its nod to four new proposals of foreign direct investment (FDI) worth Rs.384.45 crore, while rejected an equal number of requests and deffered five others. Among those got clearance, two are related to pharmaceuticals sector and one each to defence and manufacturing. The clearance came based on the recommendations of the Foreign Investment Promotion Board (FIPB) in its meeting held on October 19. “…The government of India has approved four (04) proposals of Foreign Direct Investment (FDI) amounting to Rs.384.45 crore,” a Finance Ministry statement said. Pharma major Lupin got approval for its Rs.331.64-crore proposal. The company had sought approval in respect of ESOPs (Employees Stock Ownership Plans) issued before June 11, ...
