Aurobindo Pharma gets USFDA EIR for Telangana facility Ruchika Sharma8 Sept 2023 10:30 AM ISTHyderabad: Aurobindo Pharma has announced that the company has received an Establishment Inspection Report (EIR) from United States Food and Drug...
Boston Scientific gets USFDA nod for latest generation WATCHMAN FLX Pro Left Atrial Appendage Closure Device Ruchika Sharma7 Sept 2023 3:30 PM ISTThe latest WATCHMAN FLX Pro device is enhanced with a coating designed to reduce device-related thrombus and enable faster, controlled healing and...
Enhance risk evaluation for Rare Inflammatory Disease drug: USFDA asks AstraZeneca Ruchika Sharma6 Sept 2023 2:30 PM ISTCambridge: The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License...
Viatris gets USFDA tentative nod for paediatric formulation of Abacavir, Dolutegravir, Lamivudine for children with HIV Ruchika Sharma5 Sept 2023 3:54 PM ISTBangalore: Viatris Inc., a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug...
Caplin Steriles receives USFDA EIR for injectable, ophthalmic manufacturing unit near Chennai Ruchika Sharma4 Sept 2023 3:19 PM ISTChennai: Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, today announced that the company has received the Establishment...
Zydus Lifesciences bags USFDA nod for antibacterial drug Erythromycin Ruchika Sharma1 Sept 2023 3:28 PM ISTThe drug will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, India.
3 baby formula makers get USFDA warning letter to correct manufacturing process controls Ruchika Sharma1 Sept 2023 1:30 PM ISTThe FDA's warning letters are not associated with any current recalls, and were related to observations following recalls by the three companies...
Janssen seeks USFDA full approval for Balversa for Urothelial Carcinoma Ruchika Sharma1 Sept 2023 12:30 PM ISTRaritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application...
Zydus Lifesciences receives USFDA approval for severe cystic acne drug Isotretinoin Ruchika Sharma31 Aug 2023 3:22 PM ISTThe drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
USFDA nod to Unichem Labs Prasugrel Tablets to reduce thrombotic CV events rate in acute coronary syndrome Ruchika Sharma31 Aug 2023 2:30 PM ISTMumbai: Unichem Laboratories Limited has announced that the company has received abbreviated new drug application (ANDA) approval for its...
Strides Singapore arm bags USFDA nod for Mycophenolate Mofetil for Oral Suspension Ruchika Sharma31 Aug 2023 1:30 PM ISTMycophenolate Mofetil for Oral Suspension belongs to a group of medicines called immunosuppressants.
Ajanta Pharma bags USFDA nod for migraine drug Topiramate ER Ruchika Sharma31 Aug 2023 11:54 AM ISTMumbai: Ajanta Pharma Limited, a speciality pharmaceutical formulation company, has received final approval from the United States Food and Drug...
