News about Quality / GMP

Marion Biotech's facility inspected by drug regulators over Uzbekistan deaths

Uzbekistan said that India-based Marion Biotech's cough syrup resulted in the deaths of 18 children in the country

Quality / GMP | 29/12/2022 | By Sudeep Soparkar |  1033

Alembic Pharma bags US FDA approval for Fulvestrant injection single-dose prefilled syringe

Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer

Quality / GMP | 26/12/2022 | By Sudeep Soparkar |  891

Alembic Pharma bags US FDA approval its first product from Jarod facility

The product approved is Supplemental Abbreviated New Drug Application (sANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg

Quality / GMP | 22/12/2022 | By Sudeep Soparkar |  1646

Lupin Pharmaceuticals issues voluntary nationwide recall of four lots of Quinapril tabs

This is due to the potential presence of N-Nitroso-Quinapril impurity

Quality / GMP | 22/12/2022 | By Sudeep Soparkar |  944

US FDA issues Form 483 to Alembic's Jarod facility

None of the observations is related to data integrity and management believes that they are addressable

Quality / GMP | 20/12/2022 | By Sudeep Soparkar |  996

Zydus Lifesciences bags US FDA approval for menopause drug

The drug will be manufactured in Moraiya, Ahmedabad, at the group's formulation manufacturing facility<br />

Quality / GMP | 05/12/2022 | By Sudeep Soparkar |  704

Dipharma receives GMP certification from Brazilian ANVISA

The Baranzate site (Italy) is the first Dipharma manufacturing facility to receive Anvisa certification<br />

Quality / GMP | 02/12/2022 | By Sudeep Soparkar |  864

Shilpa Medicare's Telangana facility bags Health Canada GMP approval

The facility is involved in the manufacturing, packaging, labelling and testing of finished dosage forms

Quality / GMP | 01/12/2022 | By Sudeep Soparkar |  702

Zydus Lifesciences bags US FDA approval to treat myxedema coma

The drug will be manufactured at the group's injectable manufacturing facility in Jarod, near Vadodara<br />

Quality / GMP | 28/11/2022 | By Sudeep Soparkar |  602

US FDA issues warning letter to Glenmark's Goa facility

The US drug regulator inspected Glenmark's Goa facility in May 2022 and issued an Official Action Indicated (OAI)<br />

Quality / GMP | 25/11/2022 | By Sudeep Soparkar |  678