Pharmaceutical-Grade Quality | GMP Certified | USP/BP Compliant
By Kaifeng Darui Pharmaceutical Co., Ltd. – Your Trusted Partner for Premium Pharmaceutical Products
About Our Folic Acid Tablets
Pharmaceutical Excellence in Every Tablet
Kaifeng Darui Pharmaceutical Co., Ltd. specializes in the production of high-quality Folic Acid Tablets that meet the strictest international pharmaceutical standards. Our state-of-the-art manufacturing facilities and rigorous quality control processes ensure consistent product excellence that healthcare providers and consumers can trust.
Quality Assurance & Compliance
Our Folic Acid Tablets are:
- GMP Certified – Manufactured in Grade D cleanroom facilities
- USP/BP Compliant – Meet or exceed USP and BP monograph specifications
- Strictly Tested – Using advanced analytical equipment including Shimadzu HPLC
- Stability Guaranteed – Extensive shelf-life testing ensures product integrity
- Regulatory Compliant – Full documentation available for regulatory submissions
Product Specifications
| Parameter | Specification |
|---|---|
| Active Ingredient | Folic Acid (Pteroylglutamic Acid) |
| Strength | Available in 0.4mg, 0.8mg, 1mg, and 5mg formulations |
| Appearance | Yellow to yellow-orange round tablets |
| Dissolution | Meets USP/BP requirements (≥70% in 1 hour) |
| Purity | ≥98.0% |
| Identification | Positive to USP/BP identification tests |
| Microbial Limits | Complies with Pharmacopoeial requirements |
| Packaging | Blister packs or bottles; customizable |
| Shelf Life | 36 months (supported by stability data) |
Health Benefits & Applications
Essential for Health and Well-being
Folic acid is a critical B vitamin that supports numerous bodily functions and is recognized for its significant health benefits:
- Pregnancy Support – Reduces risk of neural tube defects and supports fetal development
- Red Blood Cell Formation – Essential for proper erythropoiesis
- Heart Health – May help reduce homocysteine levels associated with cardiovascular risks
- Cellular Growth – Supports DNA synthesis and cell division
- Cognitive Function – Associated with neurological health and cognitive maintenance
Clinical Applications
Our Folic Acid Tablets are formulated to address specific health needs:
- Prenatal Care – Prescribed before and during pregnancy (typically 0.4mg-0.8mg)
- Anemia Treatment – For folate deficiency anemia (typically 1mg-5mg)
- Nutritional Supplementation – For individuals with dietary restrictions or increased needs
- Adjunctive Therapy – Often prescribed alongside other medications where folate supplementation is indicated
Manufacturing Excellence
Advanced Production Capabilities
At Kaifeng Darui Pharmaceutical, we’ve invested in cutting-edge manufacturing technology:
- 700㎡ API Facility – Dedicated synthesis and purification areas
- Grade D Cleanrooms – Ensure product purity and quality
- Advanced Analytics – Shimadzu HPLC, Fourier-transform IR spectrometers, and stability chambers
- Environmental Responsibility – Automated RCO exhaust treatment and wastewater management systems
- Quality Control – 100% batch testing with full documentation
Certifications & Recognition
Our commitment to quality is backed by prestigious certifications:
- National High-Tech Enterprise (2023)
- Henan Provincial Innovative SME (2022)
- GMP Compliance – All production facilities
- Quality Management System – ISO 9001 certified processes
Customized Solutions
Contract Manufacturing Services
We offer comprehensive contract manufacturing services for pharmaceutical companies and distributors:
- Formula Development – Customized formulations based on your specifications
- Strength Options – Multiple dosage strengths available (0.4mg, 0.8mg, 1mg, 5mg)
- Packaging Flexibility – Blister packs, bottles, bulk containers
- Private Labeling – Full branding options for your products
- Regulatory Support – Documentation for regulatory filings
- Quality Assurance – Comprehensive testing and validation
Bulk Supply Options
For pharmaceutical companies, distributors, and large healthcare providers, we offer:
- Competitive Pricing – Volume-based pricing structures
- Consistent Supply – Reliable production scheduling
- Neutral Packaging – Available for repackaging or further processing
- Documentation – Complete product dossiers and quality certificates
- Logistics Support – Global shipping and import assistance
Research & Development Collaboration
Our team of 20+ R&D specialists can support your product development needs:
- Formulation Optimization – Enhance stability, bioavailability, or other parameters
- Custom Analysis – Specialized testing for your specific requirements
- Technical Transfer – Support for incorporating our products into your formulations
- Joint Development – Collaborative research for novel applications
Quality Control Process
Stringent Testing Protocols
Every batch of our Folic Acid Tablets undergoes rigorous testing:
- Raw Material Testing – Verification of all incoming materials
- In-Process Controls – Monitoring at critical production stages
- Finished Product Testing – Comprehensive analysis including:
- Assay (Content Uniformity)
- Dissolution Profile
- Disintegration Time
- Hardness & Friability
- Microbial Limits
- Stability Studies – Real-time and accelerated testing
- Batch Documentation – Complete records for traceability
Quality Assurance System
Our quality commitment extends throughout our operation:
- Documentation – Comprehensive batch records and analytical reports
- Validation – Process, cleaning, and analytical method validation
- Training – Continuous staff education on GMP requirements
- Internal Audits – Regular self-inspection programs
- Change Control – Strict management of all process modifications
- CAPA System – Corrective and preventive action management
Why Choose Kaifeng Darui Pharmaceutical
Our Commitment to Excellence
- Experience – Established pharmaceutical manufacturer with proven expertise
- Innovation – 12 utility patents and continuous R&D investment
- Quality – GMP compliance and rigorous quality standards
- Reliability – Consistent product quality and on-time delivery
- Flexibility – Customized solutions tailored to your needs
- Support – Comprehensive technical and regulatory assistance
Our Values
At Kaifeng Darui Pharmaceutical, we operate by our guiding principle: “Survival through quality, growth through talent; innovation drives development, efficiency stems from management.” This philosophy drives our commitment to delivering pharmaceutical products of the highest standard.
Specifications & Documentation
Available Documentation
We provide comprehensive documentation to support your regulatory and quality requirements:
- Product Specification Sheets
- Certificates of Analysis
- Stability Studies
- Manufacturing Process Summaries
- Regulatory Compliance Statements
- Safety Data Sheets
- Validation Reports (upon request)
Regulatory Information
Our Folic Acid Tablets comply with international pharmacopoeial standards:
- United States Pharmacopeia (USP)
- British Pharmacopoeia (BP)
- European Pharmacopoeia (Ph. Eur.)
- WHO Good Manufacturing Practices
Contact Us
Get in Touch
For inquiries about our Folic Acid Tablets, contract manufacturing services, or bulk supply options, please contact our dedicated sales team:
Email: info@daruipharm.com
Phone: +86-13837178289
Address: Kaifeng Fine Chemical Park, Henan, China
Request Information
Complete our quick form to request:
- Product samples
- Detailed specifications
- Customization options
- Pricing information
- Contract manufacturing details
Global Distribution
Kaifeng Darui Pharmaceutical Co., Ltd. supplies pharmaceutical products to markets worldwide. Contact us to discuss import requirements and logistics options for your region.
FAQ Section
Frequently Asked Questions
Q: What dosage strengths of Folic Acid Tablets do you offer?
A: We manufacture Folic Acid Tablets in multiple strengths including 0.4mg, 0.8mg, 1mg, and 5mg to meet various clinical and nutritional needs.
Q: Are your products suitable for pregnant women?
A: Yes, our Folic Acid Tablets are manufactured to pharmaceutical standards and are suitable for prenatal supplementation as prescribed by healthcare providers.
Q: What is your minimum order quantity for bulk purchases?
A: Minimum order quantities vary based on product specifications and packaging requirements. Please contact our sales team for specific information.
Q: Can you produce custom formulations with folic acid and other nutrients?
A: Yes, our R&D team can develop custom formulations combining folic acid with other vitamins or minerals according to your specifications.
Q: Do you provide private labeling services?
A: Yes, we offer comprehensive private labeling options including custom packaging design, branding, and market-specific labeling requirements.
Q: What certifications do your manufacturing facilities hold?
A: Our facilities are GMP certified, and we hold certifications as a National High-Tech Enterprise and Henan Provincial Innovative SME.
Q: What testing is performed on your Folic Acid Tablets?
A: Each batch undergoes comprehensive testing including assay, dissolution, disintegration, hardness, friability, and microbial limits testing according to pharmacopoeial standards.
Q: Can you provide documentation for regulatory submissions?
A: Yes, we provide comprehensive documentation packages including specifications, certificates of analysis, stability data, and other technical information required for regulatory filings.
