Exhibiting at FOOD INGREDIENTS CHINA 2025

ANHUI SUNHERE PHARMACEUTICAL EXCIPIENTS CO., LTD.（安徽山河药用辅料股份有限公司）is a publicly listed pharmaceutical excipient manufacturer based in Huainan, Anhui Province, China. As a pioneering enterprise in the pharmaceutical ingredient sector, Sunhere has built an integrated business model combining R&D, production, sales, and export of high-purity pharmaceutical excipients widely used in solid oral dosage forms.

Core Business and Product Offerings

Sunhere specializes in the manufacturing and global distribution of pharmaceutical excipients for use in tablet, capsule, and other dosage form manufacturing. Their product portfolio includes:

• Microcrystalline Cellulose (MCC)

  • Used as a binder and filler in tablet formulations.

• Magnesium Stearate

  • A lubricant for tablets and capsules.

• Sodium Starch Glycolate

  • A superdisintegrant for tablets.

• Hypromellose (HPMC / Hydroxypropyl Methylcellulose)

  • A film former and controlled-release matrix.

• Povidone K30

  • A binder and solubilizer.

• Silicon Dioxide

  • Used as an anti-caking and glidant agent.

• Polyacrylic Resin II, III, IV

  • Enteric and sustained-release coating agents.

• Sodium Stearyl Fumarate

  • A lubricant alternative with low impact on tablet hardness.

Products are manufactured in compliance with ChP, USP, EP, JP standards, depending on customer needs.

Specialization and Unique Selling Proposition

Sunhere’s key differentiators include:

• In-house pharmaceutical excipient R&D team comprising formulation scientists and polymer chemists.
• Production technologies optimized for high batch consistency, compressibility, and purity.
• Strong expertise in functional excipients for controlled-release and gastro-resistant drug delivery systems.
• A proprietary quality control system including HPLC, GC, IR, and particle analysis.

Sunhere is one of the few Chinese excipient manufacturers offering a full excipient solution for both generic and branded pharmaceutical manufacturers.

Target Markets

Sunhere exports to over 70 countries, with major markets in:

• North America
• Europe
• South Asia
• South America
• Middle East and Africa

Customer segments include pharmaceutical formulation companies, contract development and manufacturing organizations (CDMOs), nutraceutical producers, and ingredient distributors.

Shipment and Trade Data

According to trade data and customs shipment records:

• Sunhere completes over 600 export shipments annually.
• Key export products: MCC 101/102, Magnesium Stearate, Sodium Starch Glycolate, and HPMC.
• Regular export destinations include India, Germany, Brazil, Egypt, and the U.S..
• Products are shipped via Shanghai Port and Ningbo Port, with export-standard documentation including DMFs, COAs, and GMP certificates.

Sunhere is listed as a preferred supplier on international sourcing platforms and is registered with major regulatory agencies.

Certifications and Compliance

Sunhere operates under cGMP-compliant manufacturing facilities and maintains:

• ISO 9001: Quality Management
• ISO 14001: Environmental Management
• OHSAS 18001: Occupational Health & Safety
• EXCiPACT Certification
• US FDA DMF filings for multiple excipients
• CEP (Certificate of Suitability) for selected excipients

All products are produced in accordance with ICH Q7A and Q10 guidelines, ensuring consistent pharmaceutical-grade quality.

Capabilities

• Facility spans over 40,000 square meters with Class D cleanrooms.
• Annual production capacity of:
  • MCC: 8,000 MT
  • Magnesium Stearate: 2,000 MT
  • HPMC: 1,000 MT
• Independent analytical laboratory with over 100 validated test methods.
• Supports DMF filings, CTD dossiers, and other international regulatory submissions.

Sunhere also offers technical support for formulation development, excipient compatibility studies, and sample assistance.

Financials

As a listed company on the NEEQ (National Equities Exchange and Quotations):

• Reported annual revenue exceeding RMB 150 million (approx. USD 21 million).
• Export revenue accounts for over 50% of total revenue.
• Consistent year-over-year growth rate of 12–15%.
• Ongoing R&D investment in new polymer excipients and co-processed blends.

Achievements and Industry Recognition

• Awarded “High-Tech Enterprise” status by Anhui Provincial Government.
• Recognized as a “Top 10 Excipient Manufacturer in China” by the China Pharmaceutical Packaging Association.
• Participated in international exhibitions including CPhI Worldwide, CPhI China, and FCE Pharma Brazil.
• Established long-term R&D partnerships with Anhui University of Chinese Medicine and China Pharmaceutical University.

Customer Testimonials

“Sunhere’s MCC meets our GMP production needs with excellent flowability and compaction properties. Their regulatory support was instrumental in our FDA ANDA filing.”
– Director of Regulatory Affairs, Generic Drug Manufacturer (USA)

“We appreciate their technical service and product consistency, especially for our high-speed tablet presses.”
– Plant Manager, Multinational CDMO (India)

ANHUI SUNHERE PHARMACEUTICAL EXCIPIENTS CO., LTD. continues to be a global excipient leader, known for quality, innovation, and regulatory excellence in the pharmaceutical ingredients industry.