Orlistat API Powder
Orlistat API Powder: High-Quality Weight Loss Ingredient
Guangzhou Jianbei Biotechnology Co., Ltd. is a leading manufacturer and supplier of Orlistat API Powder. Our company stands out for its strong technical R&D strength, reliable product quality, and outstanding market competitiveness. We offer high-purity product that meets stringent quality standards, ensuring our customers receive top-notch ingredients for their weight loss formulations.
Product Introduction
The product is a potent active pharmaceutical ingredient used in the production of weight loss medications. It works by inhibiting pancreatic lipases, enzymes that break down triglycerides in the intestine. This mechanism reduces the absorption of dietary fat, making it an effective tool in combating obesity. Our product is manufactured under strict GMP conditions, guaranteeing consistent quality and purity for pharmaceutical applications.
Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Purity | ≥ 99.0% |
| Melting Point | 42-45°C |
| Loss on Drying | ≤ 0.5% |
| Heavy Metals | ≤ 10 ppm |
| Residual Solvents | Meets ICH guidelines |
Uses and Applications
The product is primarily used in the production of prescription and over-the-counter weight loss medications. It's particularly effective for:
- Formulating oral capsules and tablets for obesity treatment
- Developing generic versions of branded weight loss drugs
- Creating combination therapies for comprehensive weight management
- Research and development of new anti-obesity formulations
Dosage and Usage
The typical dosage of Orlistat in finished products is 120 mg three times daily with meals. However, the exact dosage and usage instructions should be determined by the pharmaceutical manufacturer based on their specific formulation and regulatory requirements.
Quality Standards and Certifications
Our Orlistat API Powder meets the highest quality standards:
- Manufactured in WHO-GMP certified facilities
- Complies with USP/EP pharmacopeia standards
- Adheres to ICH Q7 guidelines for API production
- Fully documented with comprehensive CoA and stability data
- Supported by a valid Drug Master File (DMF)
Packaging
We offer flexible packaging options to meet diverse customer needs:
- 1 kg aluminum foil bags
- 5 kg fiber drums
- 25 kg fiber drums
- Custom packaging available upon request
All packaging is designed to protect the product from light, moisture, and contamination during storage and transport.
Why Choose Us
Guangzhou Jianbei Biotechnology Co., Ltd. is your ideal partner for the product:
- Advanced R&D capabilities ensure high-quality products
- Strict quality control measures guarantee consistency
- Large inventory for quick order fulfillment
- Competitive pricing for bulk orders
- Excellent customer service and technical support
- Customization options to meet specific requirements
FAQ
Q1: Is your product suitable for generic drug production?
A1: Yes, our product is ideal for generic formulations, meeting all necessary quality and regulatory standards.
Q2: Do you provide stability data for the product?
A2: Absolutely. We offer comprehensive stability data to support our customers' regulatory filings and quality assurance processes.
Q3: Can you supply the product in small quantities for R&D purposes?
A3: Yes, we offer flexible order quantities to accommodate both R&D needs and large-scale production requirements.
Q4: What is the shelf life of your product?
A4: Our product typically has a shelf life of 2 years when stored properly under recommended conditions.
Q5: Do you offer technical support for formulation development?
A5: Yes, our team of experts is available to provide technical assistance and formulation guidance to our customers.
Q6: Can you provide documentation for regulatory submissions?
A6: Certainly. We offer full documentation support, including DMF access, to assist with regulatory filings in various markets.
Contact Us
For inquiries about our Orlistat API Powder or to request a quote, please contact us at h33727868@gmail.com. Our team is ready to assist you with any questions and provide the information you need.
