News about Quality / GMP

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 |  918

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 |  1662

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 |  976

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 |  1018

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 |  734

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 |  911

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 |  719

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 |  621

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 |  712

USFDA gives Zydus Lifesciences final approval to market Famotidine Injection

The drug will be produced at the group's injectable manufacturing facility in Jarod, India, near Vadodara

Quality / GMP | 24/11/2022 | By Sudeep Soparkar |  603