USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations

USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time

Gland Pharma receives approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis

Lupin receives USFDA approval for travoprost ophthalmic solution

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.