Strides receives USFDA approval for Sevelamer Carbonate for oral suspension

The products will be manufactured at the company's facility in Bengaluru

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated

Zydus receives final USFDA approval for Erythromycin Tablets

Erythromycin tablets is used to prevent and treat infections in many different parts of the body

Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection

The inspection has concluded successfully on 1st September 2023 without any critical/major observation

USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia

Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension

The approval bolsters the company's Mycophenolate Mofetil portfolio

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US

Unichem receives ANDA approval for Prasugrel Tablets

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population

Briefs: Granules India

Granules India received approval from Brazilian Health Regulatory Agency ANVISA

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition

Lynparza plus abi/pred approved in Japan for treatment of prostate cancer

First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat

Jiangsu Hengrui Pharmaceuticals gets NMPA approval of oteseconazole Ccapsules

Oteseconazole Capsules were found to be safe and more effective than fluconazole

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.