Home Subjects Approval

Approval

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...

The FDA just approved a drug to treat smallpox in case of a bioterrorism...

Most of us don't get the smallpox vaccine anymore, which means we'd be vulnerable to a bioterrorism attack using the virus. The FDA just approved a drug that could be used to treat smallpox. The disease was officially eradicated...

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...

Strides Shasun receives USFDA approval for Ibuprofen OTC Tablets

Product further strengthens Strides Ibuprofen franchise for the US markets  Bangalore, July 04, 2018: Strides Shasun Limited today announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received final approval for Ibuprofen Tablets USP, 200 mg (OTC)...

DIL Ltd. approves Scheme of Amalgamation with subsidiary, Fermenta Biotech Ltd.

~Amalgamation to be value accretive to shareholders in addition to other benefits~ Mumbai, June 24, 2018: DIL Ltd. (BSE: DIL) today announced that the Board of Directors at its meeting held on June 21, 2018 has approved the Scheme of Amalgamation ('Scheme')...

WuXi STA first CDMO to support the approval of an innovative drug in China...

WuXi STA enables Ascletis to receive NDA Approval from China FDA for Ganovo® Shanghai, June 15, 2018: STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, announces that its partner, Ascletis has received approval from China Food and Drug Administration...

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...