At Farmson Basic Drugs, quality and innovation drive our commitment to delivering top-tier pharmaceutical ingredients. Our state-of-the-art process for producing caffeine exemplifies this dedication, combining advanced chemical techniques with stringent quality control to ensure the highest purity and consistency.
Advanced Production Process
Seven-Stage Chemical Conversion:
We manufacture caffeine through a process involving seven distinct chemical conversions. This multi-step method allows us to achieve better control over impurities in the final drug substance, ensuring a purer and safer product.
Isolation of Intermediates:
- Four Key Intermediates: During production, we isolate four intermediates with well-defined specifications.
- Enhanced Impurity Control: By rigorously monitoring impurities and starting materials at each stage, we effectively purge impurities formed early in the process, minimizing carryover into the final product.
Superior Quality Assurance
Impurity Management:
- All potential genotoxic impurities and nitrosamine impurities are meticulously controlled throughout the production process.
- These stringent measures ensure that our caffeine meets the highest quality standards.
Compliance with Global Pharmacopoeias:
- Our caffeine product complies with the requirements of major pharmacopoeias, including IP, EP/BP, USP, and JP.
- It is produced in polymorph Form-II, a stable and consistent form that enhances its performance and reliability.
Customizable Particle Size:
- Farmson Basic Drugs is capable of providing caffeine in various particle sizes, tailored to meet specific customer requirements.
Robust Manufacturing and Regulatory Standards
Validated Cleaning Procedures: Our production facility follows validated cleaning procedures in line with UFDA/EUGMP guidelines, significantly reducing the risk of contamination.
High-Volume Production Capability: Farmson Basic Drugs is equipped to produce caffeine on a large scale, targeting 300 MT per month with the potential to extend production up to 600 MT per month.
Future Regulatory Filings: To further validate our manufacturing excellence, Farmson Basic Drugs will be filing for USDMF and CEP certifications, underscoring our commitment to meeting international regulatory standards.
Conclusion
Farmson Basic Drugs continues to set new benchmarks in caffeine production by integrating advanced chemical processes with rigorous quality control measures. Our approach not only ensures a high-purity product but also reinforces our commitment to global quality standards and customer satisfaction. Whether you require consistent polymorphic stability or customizable particle sizes, Farmson Basic Drugs stands ready to meet the evolving needs of the pharmaceutical industry.
Discover the difference of precision-engineered caffeine with Farmson Basic Drugs—a leader in quality, innovation, and reliability.