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

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

J.B. Chemicals & Pharmaceuticals Limited has received approval from United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Amitriptyline Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, which is indicated for relief of symptoms of depression.

Concord Biotech receives EIR from USFDA for API facility at Dholka

Concord Biotech Limited has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the inspection carried out by them at our API facility at Dholka from 28th April 2025 till 2nd May 2025.

The USFDA has officially concluded its inspection, which is now closed under 21 CFR 20.64(d)(3). This closure indicates that no regulatory action is required, and the facility is permitted to continue its operations without any restrictions.

Gland Pharma receives EIR from US FDA for JNPC facility, Visakhapatnam

Gland Pharma Limited has announced that following the Pre-approval inspection (PAI) for Sterile APIs at the Company's Facility at JNPC, Visakhapatnam between February 19, 2025, and February 25, 2025; the Company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection.