WHO-GMP & DCGI Certified
AAYUNEX HEALTHCARE

Certifications & Compliance

Quality at Aayunex Healthcare isn't a claim — it's backed by internationally recognised certifications and a compliance framework that governs everything we manufacture and distribute.

W
WHO-GMP CertifiedMANUFACTURING STANDARD
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ISO 9001:2015 CertifiedQUALITY MANAGEMENT SYSTEM
Our certifications

The Standards Behind Every Product

Certifications aren't decoration on a website — they're a commitment to a specific, auditable way of working. Here's what each of ours actually means for the medicines you receive from Aayunex Healthcare.

WHO-GMP

World Health Organization — Good Manufacturing Practices

WHO-GMP certification confirms that our manufacturing processes meet the quality benchmarks set by the World Health Organization for pharmaceutical production — covering everything from raw material sourcing to finished product release.

  • Controlled, documented manufacturing processes at every stage
  • Consistent product quality, batch after batch
  • Trained personnel and validated equipment
  • Traceability from raw material to finished product
ISO 9001:2015

International Organization for Standardization — Quality Management

ISO 9001:2015 certifies that our quality management system meets international standards for consistency, customer focus, and continuous improvement — applied across manufacturing, quality control, and how we work with our franchise and distribution partners.

  • Documented, repeatable quality processes company-wide
  • Regular internal review and continuous improvement
  • Clear accountability at every stage of production
  • A framework for consistent partner and customer experience
Certificate copies are available on request for franchise partners, stockists, and institutional buyers who require them for their own compliance or tender documentation. Contact us using the details below.
How our products are made

Third-Party Manufacturing

Aayunex Healthcare formulations are manufactured through trusted third-party manufacturing units, selected specifically for their WHO-GMP and ISO 9001:2015 certified facilities. This allows us to focus on formulation quality, quality control, and partner support, while production takes place at units that meet the same certified standards we hold ourselves to. Every manufacturing partner is vetted for certification, documented process compliance, and consistent batch quality before we work with them.

Where we hold the line

What We Don't Compromise On

Every pharma company says it values quality. What actually matters is what happens when quality and convenience pull in different directions. Here's where we don't bend, even when it would be easier to:

A batch that fails internal checks doesn't shipEven under order pressure or delivery deadlines, a batch that doesn't clear our internal quality checks is not released — no exceptions made to meet a timeline.
No partner is onboarded without valid documentationDrug licence and GST verification happens before any franchise or stockist agreement is signed, regardless of order size.
Composition is never quietly alteredWhat's on the label is what's in the formulation — sourcing changes, if ever required, are validated before they reach production.
Quality issues are addressed, not deflectedIf a partner or patient raises a genuine quality concern, it goes to our quality team for review — it isn't dismissed to protect a sale.
Beyond the certificate

Our Team Doesn't Just Trust the Certification — We Inspect Every Step Ourselves

WHO-GMP and ISO 9001:2015 certification set the standard we're held to. But certification is periodic — our own inspection isn't. A dedicated in-house quality team at Aayunex Healthcare checks medicine quality, reviews the manufacturing process, and monitors packaging and documentation continuously, batch after batch, not just at audit time.

Medicine quality checksFormulations are checked against composition and purity standards before any batch is cleared for release.
Manufacturing process reviewOur team monitors each stage of production to confirm it follows documented, validated procedures.
Packaging & labelling checksEvery batch is reviewed for correct labelling, packaging integrity, and accurate product information.
Documentation & traceabilityBatch records are maintained and reviewed so any product can be traced back through its full manufacturing history.
This internal inspection runs alongside our WHO-GMP and ISO 9001:2015 certified systems — the certifications set the standard, our team makes sure it's actually met, every time, not just when an auditor is present.
Our commitment

Quality Policy

"Aayunex Healthcare is committed to manufacturing and delivering pharmaceutical products that consistently meet WHO-GMP and ISO 9001:2015 standards, applicable regulatory requirements, and the expectations of the patients and partners who depend on us — through disciplined processes, ongoing quality review, and a refusal to compromise on formulation integrity at any stage."

Regulatory compliance

How We Stay Compliant

Beyond our certifications, Aayunex Healthcare operates within the regulatory framework governing pharmaceutical manufacturing and distribution in India.

Drugs & Cosmetics Act complianceManufacturing and marketing practices aligned with the Drugs and Cosmetics Act, 1940, and its associated rules.
Valid drug licensingProducts manufactured and marketed under valid drug licences issued by the applicable State Drug Control authorities.
GST & statutory registrationFull compliance with applicable tax registration and statutory filing requirements.
Labelling & packaging standardsProduct labelling and packaging follow applicable pharmaceutical labelling regulations for accuracy and patient safety.
Partner documentation checksFranchise partners and stockists are onboarded only after valid drug licence and GST verification.
Data protection compliancePersonal and business information handled in line with India's Digital Personal Data Protection Act, 2023.
Behind the scenes

Our Quality Assurance Process

Raw material verificationEvery input is checked against composition and purity standards before it enters production.
Controlled manufacturingProduction follows documented, validated processes in line with WHO-GMP requirements.
In-process quality checksProducts are tested at multiple stages of production, not just at the end.
Final release testingNo batch is released for distribution until it clears final quality control checks.
Post-market monitoringWe track feedback and any quality concerns raised by partners or patients after distribution.
Common questions

Certifications & Compliance — Frequently Asked Questions

Can I get a copy of your WHO-GMP and ISO 9001:2015 certificates?

Yes. Certificate copies are available on request for franchise partners, stockists, institutional buyers, and anyone who needs them for their own compliance or tender documentation. Reach out using the contact details on this page.

Are all Aayunex Healthcare products manufactured under these certifications?

Yes — WHO-GMP and ISO 9001:2015 standards apply across our manufacturing process, not to a select few products. This is a company-wide quality system, not a claim limited to specific formulations.

How often are these certifications reviewed or renewed?

WHO-GMP and ISO 9001:2015 certifications require periodic audit and renewal by the certifying bodies, in line with their standard renewal cycles. Our internal quality team's checks, by contrast, run continuously between those audits — see the section above on our in-house inspection process.

What should I check before trusting any pharma company's quality claims?

Ask to see the actual certificate, not just a logo on a website. Ask whether certification covers the whole manufacturing process or only part of it. And ask how quality is monitored between audits — a certificate confirms a standard was met at one point in time; ongoing internal checks confirm it's still being met today.

Need Certificate Copies or Compliance Documentation?

Franchise partners, stockists, institutional buyers, and regulatory bodies can request certificate copies and compliance documentation directly from us.

General Enquiries
Aayunex Healthcare Pvt. Ltd.
Registered Office
Aayunex Healthcare Pvt. Ltd.
Plot No. 883, Sindhora Varanasi
Uttar Pradesh, India, 221208