ORi Bionature's Verifications

SIRIM-Certified GMP Manufacturing Facility (MS 1514:2009)

ORi Bionature & ORB Cosmex operates under stringent quality control protocols and is officially recognized as a Good Manufacturing Practice (GMP) facility by SIRIM QAS International.

  • Standardized Compliance (GMP 1): We strictly adhere to MS 1514:2009 standards, ensuring our production processes, from raw material receiving to final packaging, meets the highest safety and hygiene requirements for food and dietary supplements.

  • Advanced Quality Assurance (GMP 2): Going beyond basic compliance, our facility implements advanced, enhanced GMP protocols. This ensures our comprehensive manufacturing lines (including chewable tablets, premix beverages, and liquid formulations) achieve pharmaceutical-grade consistency, safety, and traceability.

Partnering with a fully SIRIM-certified OEM ODM ensures your brand is market-ready, safe for consumers, and compliant with all local regulatory audits.

JAKIM Halal-Certified OEM ODM/Private Label Manufacturer

ORi Bionature & ORB Cosmex are officially recognized Halal-certified manufacturers by the Department of Islamic Development Malaysia (JAKIM)

  • 100% Halal Compliance: We formulate, manufacture, and distribute exclusively Halal-compliant dietary supplements, functional foods, skincare & cosmetics.

  • Strict Ingredient Sourcing: Every raw material and bio-active ingredient we procure undergoes rigorous vetting to ensure it meets JAKIM’s stringent Islamic dietary and ethical standards.

  • Global Market Readiness: Our official JAKIM Halal certification allows your private label brand to confidently enter domestic and international Halal markets with full regulatory backing.

Ministry of Health (MOH) / KKM Compliant Manufacturing

Navigating health regulations is complex. ORi Bionature & ORB Cosmex ensures that every product manufactured strictly complies with the guidelines set by the Ministry of Health Malaysia (MOH) / Kementerian Kesihatan Malaysia (KKM).

  • Cosmetic Compliance (NPRA): We assist brand owners in securing Notification (NOT) numbers through the National Pharmaceutical Regulatory Agency (NPRA), ensuring your skincare and cosmetic lines are legally clear for the market.

  • Dietary Supplement Registration: Our regulatory team helps classify and register health supplements, functional foods, and traditional medicines, guiding you through the process of obtaining official MAL registration numbers where applicable.

  • Food Safety Standards: All ingestible products are manufactured under strict adherence to KKM’s Food Safety and Quality Division (FSQ) guidelines.

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SIRIM & MOH Certified HACCP Facility (Hazard Analysis Critical Control Point)

ORi Bionature & ORB Cosmex’s manufacturing facility is officially HACCP certified by both the Ministry of Health (MOH) Malaysia and SIRIM QAS International.

  • Proactive Risk Management: We implement rigorous Hazard Analysis and Critical Control Point (HACCP) protocols to prevent biological, chemical, and physical contamination during the production of all ingestible products.

  • Uncompromising Food Safety: From raw material receiving to final packaging, our systematic approach guarantees the highest level of hygiene and safety for your dietary supplements and functional foods.

  • Global Export Readiness: Because HACCP is an internationally recognized standard, our certification ensures your private label products face zero regulatory friction when entering global markets.

MeSTI-Certified Food Safety by the Ministry of Health (MOH)

ORi Bionature holds the official MeSTI (Makanan Selamat Tanggungjawab Industri) certification, a vital food hygiene standard enforced by the Ministry of Health Malaysia (MOH / KKM).

  • Statutory Compliance: Our manufacturing premises strictly adhere to national regulations for operational control, facility hygiene, and safe food processing.

  • Guaranteed Consumer Safety: MeSTI compliance ensures that all functional foods, premix beverages, and dietary supplements we produce are safe for public consumption and free from contamination risks.

  • Integrated Quality Assurance: As a foundational prerequisite, our MeSTI certification works hand-in-hand with our advanced GMP and HACCP protocols to deliver uncompromising product quality.

 

SIRIM-Certified ISO 22000 (Food Safety Management System)

ORi Bionature operates under the globally recognized ISO 22000 standard for Food Safety Management Systems (FSMS), with official certification awarded by SIRIM QAS International.

  • End-to-End Hazard Control: We maintain a comprehensive framework that systematically identifies, prevents, and controls food safety hazards across the entire manufacturing supply chain.

  • International Trust & Export: Because ISO 22000 is an internationally harmonized standard, your private label dietary supplements and functional foods are instantly recognized as safe and compliant for global distribution and export.

  • Integrated Quality Assurance: Our ISO 22000 system works seamlessly alongside our GMP, HACCP, and MeSTI certifications to guarantee uncompromising pharmaceutical-grade quality and consumer safety.

U.S. FDA Registered Manufacturing Facility

ORi Bionature is an officially registered facility with the United States Food and Drug Administration (U.S. FDA), enabling global brands to confidently manufacture products for the American market.

  • U.S. Market Export Ready: Our facility is fully authorized to manufacture, process, pack, and store dietary supplements, functional foods, and beverages intended for export to and consumption within the United States.

  • Global Standard Compliance: We strictly adhere to international food safety protocols and U.S. FDA facility guidelines, ensuring comprehensive traceability, hygiene, and product integrity.

  • Seamless Cross-Border Trade: Partnering with an FDA-registered OEM ODM or private label contract manufacturer eliminates regulatory friction, allowing your private label brand to expand into the lucrative U.S. market with ease.

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