Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank

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).

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

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

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