Injectable Grade Chondroitin Sulfate Powder CEP & DMF Supported

Injectable Grade Chondroitin Sulfate Powder

Products Description

Chondroitin Sulfate is a naturally occurring glycosaminoglycan (GAG) found in cartilage tissue, widely used in joint health, osteoarthritis treatment, and injectable pharmaceutical formulations.

We offer Injectable Grade Chondroitin Sulfate manufactured under a stringent GMP system, fully compliant with European Pharmacopoeia (EP) and United States Pharmacopeia (USP) standards, and supported by a valid CEP certificate and DMF documentation.

This product is specifically designed for highly regulated markets and long-term commercial injectable products where compliance, sterility, traceability, and supply stability are critical.

Suitable for injectable pharmaceutical and advanced medical applications requiring rigorous regulatory assurance.

Functions & Benefits

Key Functions
1. Supports cartilage structure and integrity
Chondroitin Sulfate is a major structural component of the cartilage extracellular matrix, helping to maintain cartilage elasticity and resilience.

2. Helps reduce joint discomfort
Commonly used in osteoarthritis-related injectable therapies to support long-term joint comfort.

3. Improves joint mobility and flexibility
Supports synovial fluid function and overall joint lubrication.

4. Suitable for synergistic injectable formulations
Compatible with other injectable agents such as Hyaluronic Acid and Glucosamine derivatives.

Key Benefits
1. Supports healthy joints and cartilage
2. Helps maintain joint flexibility and mobility
3. Suitable for long-term therapeutic use
4. Ideal for combination injectable joint-health formulations

Specifications

(Typical specifications; detailed COA available upon request)

✔ Fully compliant with EP and USP requirements
✔ Suitable for injectable pharmaceutical registration

Regulatory & Compliance Support

Our Injectable Grade Chondroitin Sulfate is backed by a complete regulatory package:

• EP and USP compliant
• CEP Certificate issued by EDQM
• DMF available for reference
• Manufactured under GMP conditions with aseptic processing

Applicable for:

1. Injectable pharmaceutical preparations

2. Advanced medical and therapeutic products

3. Suitable for regulated markets including EU, USA, Latin America, Southeast Asia, and other regions requiring CEP- and DMF-supported materials.

Applications

Recommended Dosage Forms

1. Sterile lyophilized powder for injection

2. Pre-filled syringes

3. Vials for reconstitution

Typical Formulation Combinations

1. Chondroitin Sulfate + Hyaluronic Acid

2. Chondroitin Sulfate + Glucosamine injectable form

3. Combination with other joint-supportive injectables

Why Choose Us?

1. Truly Registration-Ready Material

Our product is not just specification-compliant, but registration-oriented:

CEP and DMF available for direct reference

Suitable for injectable pharmaceutical and high-end medical projects

Reduces regulatory risk and development uncertainty

2. Consistent and Reproducible Quality

Strict control over molecular weight and polydispersity

Controlled sulfation degree and batch-to-batch consistency

Tight control of endotoxins, sterility, and particulate matter

This makes the product highly suitable for long-term commercial supply of injectables.

3. Registration-Oriented Technical Support

Beyond supplying raw material, we actively support customer projects:

CEP / DMF referencing support

Technical and regulatory documentation assistance

Sterility assurance and validation support

Responsive communication throughout development and registration stages

4. Practical Alternative to Traditional Suppliers

While maintaining international regulatory standards, we offer:

Faster response and project coordination

Flexible supply and MOQ options

Strong collaboration during registration and commercialization

5. Built for Long-Term Cooperation

We focus on:

Stable, long-term supply with assured sterility

Multi-country registration support

Partnership-based cooperation rather than one-time transactions

7. Target Customers

Pharmaceutical companies (injectable dosage forms)

Biotechnology and medical device companies

Distributors serving regulated injectable markets

8. Key Value Statement

A CEP-certified, DMF-supported injectable chondroitin sulfate designed for regulated markets and long-term therapeutic success. Low protein (≤1.0%) and ultra-low endotoxin (≤0.1 EU/mg), designed to minimize immunogenic and pyrogenic risks for injectable applications.

FAQ

Q: What is the minimum order quantity (MOQ)?‌
A: The MOQ varies by product and packaging, but typically starts at 100kg for bulk orders.

‌Q: How is the product packaged?‌
A: It comes in 1kg or 5kg bags, vacuum-sealed for stability, with options for custom packaging.

‌Q: What are the shipping terms?‌
A: We offer FOB, CFR, and CIF shipping terms, with lead times of 15-30 days after payment confirmation.

‌Q: How do you ensure product quality?‌
A: Through rigorous testing (e.g., HPLC, microbiological assays) and compliance with cGMP standards.

‌Q: Can you provide samples?‌
A: Yes, we can send free samples for your testing, subject to MOQ requirements.

‌Q: What is the shelf life of the product?‌
A: 24 months when stored in a cool, dry place away from direct sunlight.

‌Q: How do I place an order?‌
A: Contact us via email or phone with your order details, and we’ll provide a quote and invoice.

‌Q: What are the payment terms?‌
A: We accept T/T, L/C, and PayPal, with a 30% deposit required for bulk orders.

‌Q: Do you offer OEM services?‌
A: Yes, we provide OEM manufacturing with custom formulations and packaging.

‌Q: How do you handle shipping and customs?‌
A: We arrange shipping and provide customs clearance documents, but additional fees may apply.

‌Q: What is the return policy?‌
A: Returns are accepted within 30 days of delivery if the product is defective or damaged.