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Strides Shasun receives USFDA Tentative Approval for Milnacipran Hydrochloride Tablets

Product approval under the para IV route  Bangalore, July 04, 2018: Strides Shasun Limited today announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received tentative approval for its Para IV filing of Milnacipran Hydrochloride Tablets, 12.5...

Glenmark Pharmaceuticals receives ANDA approval for Tacrolimus Ointment, 0 1 pc

Mumbai, April 21, 2018: Pharma Major.Glenmark Pharmaceuticals on Wednesday said that Glenmark Pharmaceuticals Inc USA has received final approval from the US health regulator for Tacrolimus ointment 0.1 per cent. The product is a generic version of Protopic ointment, of Leo...

Government approves FDI worth Rs 4,000 crore by four pharma firms

New Delhi, June 18, 2015: Proposals for foreign direct investment amounting to around Rs 4,000 crore by four pharma and medical devices firms, including Torrent Pharmaceuticals BSE 1.82 % and Biocon's research services arm Syngene, were today approved by...

Arthroscopy implants made from VESTAKEEP ® PEEK are now CE approved

Bengaluru, January 30, 2016: Polyetheretherketone (PEEK) suture anchors and Softfix-PK interference screws manufactured by BIOTEK, an Indian manufacturer of arthroscopy implants, have received the CE mark certificate and Indian FDA approval. All these next generation arthroscopy implants are...

Lupin gets tentative USFDA approval for Testosterone gel

Mumbai, April 21, 2018: Pharma major Lupin on Wednesday said that it has received tentative approval for its Testosterone Gel, 1.62 per cent (20.25 mg/1.25 gm actuation) from the United States Food and Drug Administration (FDA) to market a generic version...

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 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...

Jubilant Life receives ANDA approval for Amantadine Hydrochloride Tablets

Mumbai, February 10, 2018: Pharma Major,Jubilant Pharma said that its wholly owned subsidiary Jubilant Life Sciences' material has received Abbreviated New Drug Application (ANDA) final endorsement for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel of Endo,...

CCI Approves The Proposed Merger Between Sun Pharma And Ranbaxy Subject To Modification

New Delhi 09, Dec 2014:The Competition Commission of India (Commission) in its meeting held on 5th December, 2014 (05.12.2014) approved the proposed merger between Sun Pharma and Ranbaxy, subject to the parties inter alia carrying out the divestiture of...

Sun Pharma says USFDA issues at Halol over, two specialty drugs may get nod

New Delhi, June 13, 2018: Sun Pharmaceutical Industries today announced the resolution of regulatory compliance issues at Halol plant. Halol plant was served a warning letter by US Food and Drug Administration in December 2015. No new products manufactured at the facility have...