§ Quality & Compliance

Approvals you can verify.

Every Newton Laboratories Private Limited formulation is manufactured, tested and released under a stack of international and national regulatory frameworks.

§ 01 — The Stack

WHO-GMP Certification

Manufacturing operations audited against the World Health Organization's Good Manufacturing Practices guidelines.

ISO 9001:2015

Quality Management System certification covering manufacturing, distribution and customer service processes.

DCGI / CDSCO Approvals

Product registrations and manufacturing licences issued by India's Central Drugs Standard Control Organisation.

FSSAI Licence

Food Safety and Standards Authority of India licence for our nutraceutical portfolio.

Schedule M Compliance

Facility design, equipment qualification and processes aligned with India's Schedule M GMP requirements.

In-house QC Laboratory

HPLC, UV-Vis, dissolution apparatus, IR spectroscopy and microbiology — every batch is tested before release.

§ 02 — Framework

How every batch is released.

01

Raw materials sourced from approved vendors with full Certificates of Analysis.

02

Every batch released only after meeting in-house and pharmacopoeial specifications.

03

Stability studies conducted under ICH Q1A guidelines for shelf-life validation.

04

Documented standard operating procedures across every department.

05

Periodic third-party audits and regulatory inspections.

06

Customer complaint and recall procedures aligned with global best practice.