Route2Health becomes Asia’s first herbal & dietary supplement manufacturer with a USP GMP Audit Certificate

Route2Health (Pvt) Limited becomes Asia’s first herbal & dietary supplement manufacturer to be awarded a USP GMP Audit Certificate

The company announced that its manufacturing facility situated at Sundar Industrial Estate, Lahore passed a Good Manufacturing Practice (GMP) audit conducted through the United States Pharmacopeia (USP) GMP Audit Program. Route2Health is the first nutritional supplement manufacturer in Asia to be awarded this prestigious certificate.

Shahnawaz Baig, MD Route2Health also explains that the company prides itself on meeting rigorous manufacturing standards. "USP’s GMP facility audit program is a testament of assurance to our customers that our products are of international standards. We gauged our robustness by getting thoroughly audited by a globally recognized third-party to provide 100% confidence to our customers,” he adds.

Through the USP GMP Audit Program, Route2Health passed a Good Manufacturing Practice (GMP) audit of its Sundar Industrial Estate facility and quality systems, including quality management, facilities and equipment, material controls, production, packaging and labeling, and laboratory controls.

The Route2Health Sundar Estate facilities, quality systems and processes were reviewed and verified as implementing FDA 21 CFR Part 111 GMPs and USP general chapter <2750> GMPs for dietary supplements.

“USP is pleased to acknowledge that Route2Health has successfully met the requirements of the USP GMP Audit Program,” said Holly Chang, Senior Director USP Technical Services. “This accomplishment demonstrates compliance with the Program’s rigorous standards and a commitment to maintaining a high level of quality at their Sundar Estate facility for manufacturing their products," she adds.

Route2Health (Pvt) Limited is a leading brand of nutritional supplements and is associated with Highnoon Laboratories Limited (PSX: HINOON), which is one of Pakistan’s most successful and progressive pharmaceutical companies, successfully operating since 1984. The company is rapidly expanding to become an international brand with its products exported to over 10 countries.

Tausif Khan, Chairman Highnoon Laboratories and Route2Health also comments that “Patient benefit is the goal whether it be pharmaceuticals or dietary supplements. We operate under an ultra-careful mindset to ensure that our products are safe and efficacious. Sundar Industrial Estate facility’s successful completion of the USP GMP Audit Program is an international affirmation of our quality mindset. We are optimistic that our USP GMP certificate will expedite our geographical expansion.”