Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).

Collaborative efforts and equitable access to diagnostic prevention needed to end TB: Dr. Mandaviya

Combating the prevalent stigma against TB in the society, India has been committed to providing, enabling and patient-centric support to all, individuals suffering from TB

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

Lupin gets USFDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023