WHO-GMP & Schedule M
All four manufacturing plants across Hyderabad, Chennai, Kolkata, and Ahmedabad are presented as compliant facilities.
Quality
Regulatory approvals, laboratory discipline, and zero-defect manufacturing.
The company profile lists WHO-GMP, Schedule M, USFDA, EU-GMP, ISO, and medical-device quality credentials across key facilities.
Quality and regulatory
Accolades and quality systems
Quality coverage spans manufacturing, environment, safety, medical devices, and market-specific approvals.
USFDA
Hyderabad API facility approval is stated from 2015 in the supplied company profile.
EU-GMP
Chennai oral-solid dosage facility is stated as approved for Europe-oriented exports.
ISO 9001:2015
Quality management system standard.
ISO 14001:2015
Environmental management system standard.
OHSAS 18001
Occupational health and safety framework.
ISO 13485
Medical device manufacturing quality system for selected inhaler products.
Operational quality
Validation, stability, and documentation
Strong quality systems support complex formulation and API programs.
- Laboratory testing and analytical method control
- Process validation and cleaning validation
- Stability testing for export markets
- Packaging standards and artwork control
- Deviation, CAPA, and continuous improvement programs
