Tag: USFDA
Zydus receives USFDA Orphan Drug Designation for Desidustat to treat Sickle...
Zydus’ NCE Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) and has the potential to increase haemoglobin and red blood cell counts
The Future of Wound Closure in India: How Material Science Is...
As the pressure on care systems increases, material science has become a decisive factor in improving outcomes, writes Dr Ashok Kumar Moharana, Chief Medical Officer, Healthium Medtech
Zydus, Formycon forge exclusive deal to license & supply Keytruda biosimilar...
The BLA application is expected to be submitted to the USFDA in the near future and is aimed at making immunotherapy affordable and accessible to patients in need
Lupin receives approval from U.S. FDA for biosimilar Armlupeg™ (Pegfilgrastim-unne)
The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.
Zydus Lifesciences Q4 net profit rises 18% on strong US, India...
Consolidated revenue from operations rose 18% YoY to Rs 6,528 crore, while EBITDA surged 30% to Rs 2126 crore
Zydus Life net profit up 30% to Rs 1,024 crore, revenue...
The company’s revenue from operations stood at Rs 5,269 crore, up 17% as compared to Rs 4,505 crore reported in Q3 FY24
Sai Life Sciences receives EIRs from USFDA for India R&D &...
The General Good Manufacturing Practices (GMP) audit was conducted at the integrated R&D campus (Unit II) in April 2024
IPA organizes 9th Advanced GMP Workshop 2024
The two-day workshop held virtually featured over 25 distinguished industry leaders, subject matter experts, and global regulators, including USFDA and CDSCO
Orchid Pharma’s PAT surges by 71.60% in Q4
Innovative drug Enmetazobactam gains EMA & USFDA approval, Orchid Pharma expands presence in the antibiotics market
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe
Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe