Aurobindo Pharma units recall products in US over manufacturing lapses Ruchika Sharma8 Nov 2022 11:28 AM ISTThe affected lot of the medication, which is used to treat high blood pressure, has been manufactured in India and marketed in the US market by...
Zydus Lifesciences gets USFDA EIR for Moraiya facility Ruchika Sharma7 Nov 2022 4:00 PM ISTAhmedabad: Global Lifesciences company, Zydus Lifesciences Ltd., today announced the receipt of an Establishment Inspection Report (EIR) from...
Pfizer Elranatamab gets USFDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma Ruchika Sharma4 Nov 2022 3:00 PM ISTNew York: Pfizer Inc. has announced that its investigational cancer immunotherapy, elranatamab, has received Breakthrough Therapy Designation from the...
Lupin bags USFDA nod for generic equivalent of Slynd Tablets Ruchika Sharma4 Nov 2022 1:28 PM ISTMumbai: Global pharma major Lupin Limited today announced that the company has received tentative approval from the United States Food and Drug...
Lupin Tarapur facility gets USFDA warning letter Ruchika Sharma3 Nov 2022 1:30 PM IST"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API),"...
Alembic Pharma bags USFDA approval for Pain relief injection Ketorolac Tromethamine Ruchika Sharma3 Nov 2022 12:30 PM ISTKetorolac Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.
Glenmark Pharma gets USFDA nod for generic version of Buphenyl tablets Ruchika Sharma3 Nov 2022 11:15 AM ISTBUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of...
Alembic Pharma secures USFDA okay for Mesalamine ER Capsules Ruchika Sharma2 Nov 2022 11:18 AM ISTMesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Alembic Pharma bags USFDA approval for Glycopyrrolate Injection Ruchika Sharma1 Nov 2022 12:33 PM ISTGlycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to...
USFDA issues 5 observations for Lupin Nagpur facility Ruchika Sharma31 Oct 2022 11:32 AM ISTMumbai: Lupin has recently announced that the US Food and Drug Administration has concluded a Pre-Approval Inspection (PAI) with five observations at...
Laurus Labs gets 1 USFDA observation for Visakhapatnam facility Ruchika Sharma29 Oct 2022 3:32 PM ISTHyderabad: Laurus Labs today announced that the US Food and Drug Administration (USFDA) has concluded a PreApproval Inspection (PAI) with...
Zydus Lifesciences bags USFDA nod for Pain relief injection Acetaminophen Ruchika Sharma29 Oct 2022 12:15 PM ISTIt is also used in combination with opioid (narcotic) medications to relieve moderate to severe pain.
