Zydus Lifesciences Limited has successfully completed a US Food and Drug Administration (USFDA) Pre Approval Inspection at its Injectable Medical Devices manufacturing facility with zero regulatory observations. The inspection represents a significant milestone for the pharmaceutical company's compliance with international manufacturing standards.

Inspection Details

The USFDA conducted a comprehensive Pre Approval Inspection (PAI) for Injectable Medical Devices at the company's Unit 9 facility. The inspection took place at Zydus Biotech Park, located in Changodar, Ahmedabad, over a four-day period from February 16 to 19, 2026.

Regulatory Significance

The inspection closure with NIL observations indicates that the facility met all USFDA regulatory requirements and manufacturing standards. This outcome demonstrates the company's adherence to Good Manufacturing Practices (GMP) and quality control measures required for pharmaceutical manufacturing operations targeting the US market.

Pre Approval Inspections are critical regulatory assessments conducted by the USFDA to evaluate manufacturing facilities before approving products for the US market. A clean inspection with zero observations is considered a positive regulatory outcome that can facilitate product approvals and market access.

Regulatory Disclosure

Zydus Lifesciences Limited made this announcement as a mandatory disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company formally notified both BSE Limited and the National Stock Exchange of India Limited about the inspection outcome on February 19, 2026.

The successful inspection outcome strengthens the company's regulatory standing and supports its manufacturing capabilities for injectable medical devices intended for international markets, particularly the United States.

Zydus Lifesciences Limited has announced receiving final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg, marking another milestone in the company's pharmaceutical portfolio expansion in the US market.

Product Specifications and Market Details

The approved product is the generic version of Tracleer® Tablets for Oral Suspension, 32 mg. Bosentan 32 mg tablets for oral suspension are specifically indicated for treating Pulmonary Arterial Hypertension (PAH) in pediatric patients.

Therapeutic Benefits and Mechanism

Bosentan functions as a dual endothelin receptor antagonist that effectively lowers high blood pressure in the lungs. The medication is specifically designed to improve exercise ability and reduce clinical worsening in children with idiopathic or congenital PAH. The dosing is typically administered based on the patient's body weight, ensuring appropriate therapeutic levels for pediatric patients.

Manufacturing and Production

The Bosentan 32 mg tablets will be manufactured at the group's formulation manufacturing facility located at SEZ, Ahmedabad. This facility represents part of Zydus's established manufacturing infrastructure that supports its pharmaceutical operations.

Regulatory Portfolio Expansion

With this latest approval, Zydus has strengthened its regulatory portfolio in the United States market. The company's filing statistics demonstrate its sustained commitment to expanding its presence in the US pharmaceutical market.

The approval adds to Zydus's growing portfolio of USFDA-approved products, reflecting the company's continued focus on addressing therapeutic needs in specialized areas such as pediatric pulmonary arterial hypertension treatment.