SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne

Lupin receives USFDA approval for Rivaroxaban Tablets

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy