Orit Lab gets USFDA nod for Fenofibrate Tablets

Pharma/BioPharma |  News | 0 Comment | 18 Feb, 2019

Alembic Pharmaceuticals Limited (Alembic) has announced that its wholly owned step down subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (US...Read more

Glenmark receives ANDA approval for Clobetasol Propionate Foam

Pharma/BioPharma |  News | 0 Comment | 18 Feb, 2019

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Foam, 0.05%, a generic version of Olux®...Read more

Lupin launches Clobazam Oral Suspension to treat seizures

Pharma/BioPharma |  News | 0 Comment | 18 Feb, 2019

Pharma major Lupin has announced the launch of Clobazam Oral Suspension, 2.5mg/mL, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin&rsqu...Read more

Glenmark to spin off its innovation business in US

Pharma/BioPharma |  News | 0 Comment | 15 Feb, 2019

Glenmark Pharmaceuticals has announced that its Board of Directors has given an in-principle approval to spin off the innovation business into a new company in the US. Setting up of the ne...Read more

Jubilant Biosys collaborates with Sanofi in CNS therapeutic area

Pharma/BioPharma |  News | 0 Comment | 14 Feb, 2019

Jubilant Biosys, a Bengaluru-based subsidiary of Jubilant Life Sciences has announced a new integrated drug discovery collaboration with Sanofi in the CNS therapeutic area. The first colla...Read more

Aurobindo completes acquisition of Apotex’s five European Biz

Pharma/BioPharma |  News | 0 Comment | 13 Feb, 2019

Aurobindo Pharma Limited, a world-leading marketer and manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has announced that it has closed the acquisition of Apo...Read more

Zydus receives USFDA approval for anticonvulsant drug

Pharma/BioPharma |  News | 0 Comment | 12 Feb, 2019

Zydus Cadila has received the final approval from the USFDA to market Carbamazepine Extended-Release Tablets USP (US RLD – Tegretol XR), 100 mg, 200 mg, and 400 mg. It will be manufac...Read more

IPA urges USTR for removal of India from Priority Watch List

Pharma/BioPharma |  News | 0 Comment | 11 Feb, 2019

IPA has drawn the attention of the USTR to the rapid progress made by India on a number of fronts which were cited by the USTR while placing India on the Priority Watch List in 2018. The 2...Read more

Alkermes announces rejection of ALKS 5461 NDA

Pharma/BioPharma |  News | 0 Comment | 04 Feb, 2019

 Alkermes plc has announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 fo...Read more

Natco Pharma submits ANDA for Ibrutinib generic

Pharma/BioPharma |  News | 0 Comment | 01 Feb, 2019

Natco Pharma Limited has announced submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for gene...Read more

Strides to acquire full stake in Vensun Pharma

Pharma/BioPharma |  News | 0 Comment | 30 Jan, 2019

Strides Pharma Science Limited has announced that its step down subsidiary Strides Pharma, Inc has entered into an arrangement to acquire 100 per cent stake in Vensun Pharmaceuticals, Inc, ...Read more

Dr Reddy's receives FDA approval for nasal spray in US

Pharma/BioPharma |  News | 0 Comment | 28 Jan, 2019

Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC have announced the approval of TOSYMRA (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA...Read more

Olon S.p.A. expands globally by acquiring Capua BioServices

Pharma/BioPharma |  News | 0 Comment | 28 Jan, 2019

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, has announced the acquisition of Capua...Read more

USFDA completes inspection at Lupin’s Indore facility

Pharma/BioPharma |  News | 0 Comment | 28 Jan, 2019

United States Food and Drug Administration (USFDA) has completed inspection at Lupin’s Pithampur Unit-2 (Indore) facility. The inspection was carried out between January 14 and Januar...Read more

Cadila collaborates with Norwegian startup for unique heart treatment

Pharma/BioPharma |  News | 0 Comment | 24 Jan, 2019

The Norwegian start-up company SERCA Pharmaceuticals has entered into a unique agreement with the Indian pharmaceutical company Cadila Pharmaceuticals. The agreement is about developing a n...Read more

Lupin receives FDA approval for Levothyroxine Sodium Tablets

Pharma/BioPharma |  News | 0 Comment | 22 Jan, 2019

Pharma major Lupin announced that it has received approval for its Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg,  88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 m...Read more

Wockhardt receives USFDA approval for Leukemia drug

Pharma/BioPharma |  News | 0 Comment | 21 Jan, 2019

Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 100mg and 400mg tablets of Imatinib Mes...Read more

Zydus receives USFDA approval for glaucoma, altitude sickness drug

Pharma/BioPharma |  News | 0 Comment | 18 Jan, 2019

Zydus Cadila has received the final approval from the USFDA to market Acetazolamide ER Capsules (US RLD – Diamox). It will be manufactured at the group’s formulations manufactur...Read more