Shandong Aonai Biopharmaceutical Builds Complete Global Compliance System: NSF GMP, FDA Registration, HACCP, ISO 9001 and Export Licenses Back Dr.kalan Pet Supplements

Shandong Aonai Biopharmaceutical Co., Ltd., a professional pet supplement manufacturer and pet supplement supplier based in Linyi City, Shandong Province, China, has established a complete, internationally recognized quality and compliance system covering production licensing, food safety management, export registration, and professional talent certification. The company's credentials — including NSF GMP certification under FDA 21 CFR Part 507, U.S. FDA facility registration, HACCP system certification, ISO 9001:2015 quality management certification, and a Qingdao Customs export registration certificate — provide global partners with a full-chain assurance framework rarely found in the pet nutrition industry.

A Complete Certification Matrix

The table below summarizes the company's core credentials:

Production Licensing: Foundation of Manufacturing Capability

The company operates under the officia l Feed Production License (No. Lu Feed Pre (2024) 16288), authorized for the production of pet additive premixed feed in three physical forms:

● Solid pet additive premix: pet soft chew supplements, pet powder supplements, and pet tablet supplements;

● Semi-solid pet additive premix: pet gel supplements and pet emulsified supplements;

● Liquid pet additive premix: pet liquid supplements and pet drop (suspension) supplements.

This production scope gives the company exceptional formulation fiexibility — from chewables and powders to gels, emulsions, liquids, and drops — enabling custom formula development across virtually every supplement format in demand in global markets. The company also handles the packing of dried pet treats and freeze-dried pet food, completing its coverage of the pet nutrition value chain.

International Quality Management Certifications NSF GMP Certification (FDA 21 CFR Part 507)

The company has achieved NSF Current Good Manufacturing Practice (GMP) certification for Food for Animals, certificate number NSF26GMP05003, audited on April 28_29, 2026 and effective May 22, 2026. The certification is based on the U.S. FDA's 21 CFR Part 507 — the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals — widely regarded as one of the most stringent food safety standards in the world. The certification was issued by NSF Shanghai Co., Ltd., a globally recognized third-party certification body, following an initial factory inspection with ongoing surveillance audits.

U.S. FDA Facility Registration

The company's manufacturing facility (DUNS number 601520043) is registered with the U.S. Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act, as amended by the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA), with registration valid through December 31, 2026. FDA facility registration is a mandatory prerequisite for exporting animal food and pet products to the United States, and together with the NSF GMP certification, it confi rms the company's readiness to serve U.S. market customers.

HACCP System Certification

The company has been certified under the Hazard Analysis and Critical Control Point (HACCP) system (certificate No. 566HACCP2500174), confi rming that its quality system conforms to the HACCP System Certification Requirements (V1.0). The HACCP framework systematically identifies and controls biological, chemical, and physical hazards throughout the production process, providing an internationally recognized layer of food safety assurance.

ISO 9001:2015 Quality Management

The company's quality management system is certified to GB/T19001-2016 / ISO 9001:2015 (certificate No. ZT-Q-25070102S, valid through July 27, 2028), covering the production of solid, semi-solid, and liquid pet additive premixed feed. The ISO 9001 certification underpins the company's process-based quality management, continuous improvement, and customer focus — the operational backbone of its consistent product quality.

Export Compliance: Customs-Registered for Global Trade

The company holds the Export Registration Certificate issued by Qingdao Customs of the People's Republic of China (certificate No. 4213PF0111), registered as an export feed and feed additive production, processing, and storage enterprise. The registration covers pet additive premixes, dried pet treats, and freeze-dried pet treats, and is valid from October 30, 2024 to October 29, 2029. This customs registration is the administrative foundation for legitimate, compliant export operations, ensuring smooth customs clearance and full regulatory traceability for international shipments.

Professional Talent: PCQI-Certified Food Safety Leadership

Behind the certifications are certified people. The company's R&D professional, Jianxin Zhang, holds the FSPCA Preventive Controls Qualified Individual (PCQI) certification for animal food (certificate No. 301e7460, completed March 11, 2025), issued through the Food Safety Preventive Controls Alliance under the FDA FSMA framework. The PCQI qualification ensures that the company's preventive control plans are developed and overseen by internationally certified professionals — the human element that makes its quality system genuinely e仟ective.

What This Means for Global Partners

For brands, distributors, and retailers evaluating a pet supplement manufacturer or pet supplement supplier, this certification matrix delivers five concrete assurances:

1. U.S. market readiness: FDA registration plus NSF GMP certification under 21 CFR Part 507 remove the two biggest compliance barriers to exporting pet supplements to the United States;

2. Global food safety alignment: HACCP and ISO 9001 certifications align the company's quality system with internationally recognized management standards;

3. Full production fiexibility: licensing across solid, semi-solid, and liquid formats enables OEM/ODM, private label, custom formula, and bulk supply programs for any supplement format;

4. Clean export compliance: Qingdao Customs registration ensures legitimate, traceable, and efficient international trade operations;

5. Certified competence: PCQI-certified personnel ensure that preventive controls are professionally designed, implemented, and maintained.

About Shandong Aonai Biopharmaceutical Co., Ltd.

Shandong Aonai Biopharmaceutical Co., Ltd. (unified social credit code 91371326MA3W9JTP1A) is a science-driven pet health enterprise located in the Wenshui Industrial Park, Pingyi County, Linyi City, Shandong Province, China. The company integrates R&D, production, and sales, with a product portfolio spanning dog joint supplements, dog multivitamins, dental care products, and digestive & probiotic supplements under its Dr.kalan brand. As an experienced pet supplement manufacturer and pet supplement supplier, the company o仟ers fiexible OEM/ODM, private label, and custom formula services to brands and distributors worldwide. Its quality assurance system is backed by an FSPCA PCQI-certified R&D team, and the company holds multiple international invention patents and patent applications covering its Dr.kalan compound probiotics and gastric acid-resistant collagen peptides. Committed to "quality first, safety first, technology driven," Shandong Aonai is dedicated to delivering safe, scientific, and premium pet health products to pets and pet parents around the world.

With a complete certification system in place, Shandong Aonai Biopharmaceutical is fully equipped to serve the most demanding markets in the world — and to grow together with partners who share its commitment to quality.