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US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy

New Delhi, January 16, 2019: Pfizer Inc. announced today that the US Food and Drug Administration (FDA) accepted for filing the company's New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted...

ICRA assigns stable outlook for Indian Pharma companies

New Delhi, January 04, 2018: ICRA has given a stable outlook on the Indian pharmaceutical industry. The headwinds from pricing pressure in large regulated markets, especially USA, increased cost related to regulatory compliances but are largely offset by growing scale of...

WuXi AppTec Partner Hutchison MediPharma Receives Approval of Fruquintinib Capsules in China

Shanghai, November 15, 2018: WuXi AppTec congratulates its partner Hutchison MediPharma (HMP) on receiving approval of Fruquintinib capsules (Elunate®) for metastatic colorectal cancer from the National Medical Products Administration of China ("NMPA") – formerly the China Food and Drug Administration....

Aurobindo Pharma gets nod from South African health authority for HIV drug

New Delhi, September 19, 2018: The Hyderabad-based drug firm said it has received approval from the South African Health Products Regulatory Authority (SAHPRA) and is now among the first few companies which have received nod for this product. New Delhi:...

WuXi AppTec Partner Hutchison MediPharma Receives Approval of Fruquintinib Capsules in China

Shanghai, September 09, 2018: WuXi AppTec congratulates its partner Hutchison MediPharma (HMP) on receiving approval of Fruquintinib capsules (Elunate®) for metastatic colorectal cancer from the National Medical Products Administration of China ("NMPA") – formerly the China Food and Drug Administration....

Eisai’s LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in...

Tokyo, Septembe 02, 2018: Eisai Co., Ltd. announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma...

Cipla Receives Final Approval for Generic Voltaren® Gel (Diclofenac Sodium Topical Gel, 1%)

Mumbai, August 10, 2018: Cipla Limited (“Cipla”) announced that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration...

Twin USFDA Approvals for Morepen Labs’ Bulk Drugs (API) Facilities

Baddi facility gets US FDA nod for bulk drug "Atorvastatin" and Masulkhana facility for "Montelukast" New Delhi, August 05, 2018: Key Highlights Baddi facility in Himachal Pradesh gets US FDA approval for cholesterol reducing bulk drug "Atorvastatin". Masulkhana facility, also in...

Lupin gets EDQM nod for its Mandideep facility

New Delhi, August 02, 2018: Drug firm Lupin today said it has received attestation from European Directorate for the Quality of Medicines (EDQM) for its Mandideep facility in Madhya Pradesh. The unit was inspected by EDQM in March this, Lupin said in a...

Lupin Goa plant gets U.K. nod

New Delhi, July 16, 2018: Lupin on Monday said it had received approval from the U.K. health regulator for its Goa facility. The facility was inspected by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) in March 2018...