Certified Excellence in Pharmaceutical Standards
Alpha & Omega Pharmaceuticals follows strict pharmaceutical quality standards, healthcare compliance systems, and certified manufacturing practices to ensure reliable and safe healthcare products for patients and healthcare providers worldwide.
Quality, Safety & Compliance at Every Level
We are committed to maintaining the highest standards of pharmaceutical quality, safety, compliance, and healthcare excellence through certified systems and advanced quality assurance processes — ensuring every product we deliver meets global expectations.
Our Certifications
GMP
WHO GMP
Good Manufacturing Practice certified globally.
FDA
USFDA
United States FDA approved facility.
9001
ISO 9001:2015
International quality management certified.
HACCP
Hazard analysis & critical control certified.
GLP
Good Laboratory Practice compliant labs.
FSSAI
PIC/S & FSSAI
International & India licensed standards.
Our Global Quality Credentials
Each certification reflects our unwavering commitment to pharmaceutical safety, international regulatory compliance, and patient-first healthcare manufacturing.
WHO-GMP Certified
Our manufacturing facility is certified by the World Health Organization for Good Manufacturing Practices, ensuring every product meets the highest global safety and quality benchmarks.
WHO GMPISO 9001:2015 Certified
Internationally recognized quality management system certification validating our documented processes, consistent quality controls, and continuous improvement culture across all operations.
ISO CertifiedQuality Assurance
Comprehensive QA systems including in-process controls, batch record review, deviation management, and final product release protocols aligned with international pharmacopoeial standards.
QA SystemsSafety Standards
HACCP, GLP, HALAL India, FSSAI, and PIC/S certifications ensure our pharmaceutical products and laboratory operations maintain the strictest safety standards at every stage.
Safety CertifiedResearch Excellence
GLP-certified research laboratories conducting formulation development, stability studies, analytical method validation, and bioequivalence testing in compliance with OECD principles.
GLP CertifiedRegulatory Compliance
USFDA registration, CDSCO compliance, and PIC/S GMP alignment ensure our products and processes meet the strictest domestic and international pharmaceutical regulatory requirements.
USFDA & CDSCOCommitted to International Quality Standards
Our pharmaceutical products undergo strict quality testing, scientific validation, and compliance procedures to ensure safety, effectiveness, and healthcare reliability at every stage.
Multi-Stage Testing
Analytical testing at raw material, in-process, and finished product stages using HPLC, dissolution, and microbiological methods.
Stability Programs
ICH-compliant long-term and accelerated stability studies conducted to establish product shelf life and storage conditions.
Compliance Audits
Regular internal and third-party audits ensuring continuous GMP compliance, regulatory readiness, and process improvement.
Our Certification Documentation
A collection of our internationally recognized pharmaceutical certifications reflecting our quality, safety, and compliance credentials.
Click any certificate image to view in full size
Our Quality Compliance Journey
A disciplined step-by-step compliance framework ensuring every pharmaceutical product meets the strictest international standards before it reaches patients.
Quality Inspection
Incoming raw material identity, purity, and potency verification by QC analysts.
Laboratory Testing
Advanced analytical testing using HPLC, dissolution, and microbiological methods.
Safety Validation
Product safety assessment, stability studies, and pharmacopoeial compliance validation.
Compliance Approval
Batch record review, regulatory documentation, and QP release authorization sign-off.
Certified Manufacturing
GMP-compliant production and GDP-certified dispatch to healthcare distribution networks.
Trusted Pharmaceutical Manufacturing Standards
Alpha & Omega Pharmaceuticals continuously focuses on maintaining global pharmaceutical standards, advanced healthcare compliance, and scientific quality systems — building trust with healthcare professionals, distributors, and patients across India and beyond.
Our certifications are not just compliance milestones — they are evidence of our daily commitment to quality, safety, and the well-being of every patient who relies on our products.
Global Standards
Aligned with WHO, ICH, USFDA, and European pharmacopoeial manufacturing standards.
Innovation Driven
Continuous R&D investment and technology upgrades to stay ahead of pharmaceutical innovation.
Patient Safety
Zero-compromise approach to product safety and end-to-end pharmacovigilance monitoring.
Expert Team
Qualified pharmaceutical scientists and quality professionals dedicated to excellence every day.
Audit Ready
Comprehensive documentation systems ensuring regulatory audit readiness at all times.
Timely Compliance
Regular renewal, re-certification, and proactive regulatory compliance management.
Offices Across India
Strategically located across three Indian states with certified manufacturing capabilities extending to India and the USA.
New Delhi
Mahipalpur, South West Delhi
New Delhi – 110037
Head Office for North India pharmaceutical marketing and distribution operations.
Andhra Pradesh
Yemmiganur
Andhra Pradesh – 518360
South India operations hub serving AP, Telangana, and surrounding healthcare markets.
Odisha
Konark, Puri
Odisha – 752111
Eastern India pharmaceutical marketing office serving Odisha and surrounding healthcare regions.
Connect With Certified Pharmaceutical Experts
Get in touch with Alpha & Omega Pharmaceuticals for trusted healthcare manufacturing and quality pharmaceutical solutions.
Contact Us