Your Strategic Gateway for Certified Traditional Remedies
The demand for Traditional and Herbal Medicines in Vietnam is deeply rooted in the culture and is experiencing a modern resurgence, driven by consumers seeking safe, natural, and scientifically validated therapeutic alternatives. However, entering Vietnam’s regulated herbal pharmaceutical sector requires strict compliance with the Ministry of Health’s rigorous standards on botanical identity, safety, and quality control.
At Sumpharma, we bridge the gap between ancient wisdom and modern regulation. We provide comprehensive, end-to-end importation, regulatory affairs (RA), and logistics solutions tailored specifically for international manufacturers of Traditional Chinese Medicine (TCM), Kampo medicine, and global herbal remedies.
Our Comprehensive Herbal Medicine Solutions
We execute every stage of the market access pipeline in strict compliance with the Vietnam Law on Pharmacy and specialized decrees for traditional products. Our core capabilities include:
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Marketing Authorization (MA) Registration: Compiling and managing technical registration dossiers to secure official Drug Registration Numbers (Số đăng ký lưu hành thuốc dược liệu / thuốc cổ truyền) from the Ministry of Health.
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Botanical Identity & Quality Evaluation: Reviewing formulation ingredients, active markers, and botanical sources to ensure absolute alignment with the Vietnam Pharmacopoeia and local regulatory updates.
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Acredited Lab Testing Setup: Coordinating with specialized, government-certified laboratories in Vietnam to perform mandatory testing for heavy metals, pesticide residues, microbial limits, and batch toxicity.
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Customs Clearance & Specialized Inspection: Managing specialized pharmaceutical customs clearance, import quotas for raw materials/finished formulations, and strict border quarantine procedures.
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GSP-Compliant Logistics: Storing sensitive herbal medicines in state-of-the-art GSP (Good Storage Practices) warehouses, utilizing precise temperature and humidity controls to prevent degradation, moisture, or active ingredient loss.
Technical Dossier & Compliance Support
Securing a registration number for herbal medicines demands rigorous proof of efficacy, safety, and manufacturing standardization. We work closely with your global RA teams to prepare and adapt:
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CoPP (Certificate of Pharmaceutical Product): Professional guidance on format alignment and proper consular legalization.
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Herbal GMP Certification Recognition: Assisting global manufacturing sites in gaining recognition for their traditional medicine GMP compliance from the Vietnamese authorities.
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Stability & Standardized Testing Data: Evaluating stability data tailored to Vietnam’s hot and humid climate (Zone IVb) and reviewing Certificates of Analysis (COA) for both active ingredients and finished products.
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Compliant Labeling & Translation: Translating and adapting traditional medical texts, indications, and usage instructions into compliant Vietnamese pharmaceutical labeling format.
Why Partner with Sumpharma?
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Specialized Regulatory Insight: Our team understands the nuances of local evaluation mindsets for traditional formulations, efficiently managing chemical and botanical data requirements to minimize dossier deficiencies.
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Infrastructure for Botanicals: We understand that herbal tablets, capsules, and liquids are highly sensitive to humidity. Our premium GSP infrastructure guarantees flawless environmental control.
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Speed to Market: By proactively auditing species identity and heavy metal data before submission, we prevent costly delays and fast-track your product launch.
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Data Integrity & Security: We maintain strict confidentiality over your proprietary formulations, extraction ratios, and technical manufacturing processes.
Expand Your Herbal and Traditional Medicine Brand into Vietnam
Partner with a compliance specialist who values the precision of modern herbal pharmaceuticals. Contact our international business development team today to schedule a confidential regulatory assessment.
SUMPHARMA – Vietnam’s Leading Company for the Import of Health Supplements, Cosmetics, and Medical Devices
Sum Pharmaceutical Investment Joint Stock Company
Headquarters: 11th Floor, West Tower, Hancorp Building, 72 Tran Dang Ninh Street, Nghia Do Ward, Hanoi City, Vietnam.
Southern Branch: 4th Floor, C.T Building, 56 Yen Thế Street, Ward 2, Tan Binh District, Ho Chi Minh City, Vietnam.
Hotline: +84 243 212 1820
Email: cskh@sumpharma.vn
