Osimertinib Mesylate Manufacturers in India

Osimertinib Mesylate is a critical Active Pharmaceutical Ingredient (API) in the pharmaceutical industry, particularly for its use in oncology. It is the mesylate salt form of Osimertinib, a third-generation tyrosine kinase inhibitor (TKI) widely used in the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. 

The demand for Osimertinib Mesylate Manufacturers in India is rising globally due to its targeted therapeutic approach, making India a prominent hub for its manufacturing.

Key Chemical Details of Osimertinib Mesylate

• CAS Number: 1421373-66-1
• Chemical Name: N-(2-{2-[4-(dimethylamino)but-2-enoxy]pyrimidin-5-yl}pyridin-3-yl)-4-(1-methylindol-3-yl)pyrimidin-2-amine mesylate
• Molecular Formula: C28H33N7O2.CH4O3S
• Molecular Weight: 596.70 g/mol
• Chemical Structure:

What is Osimertinib Mesylate?

Osimertinib Mesylate is a highly potent API that works by irreversibly binding to the mutant EGFR receptor, thereby inhibiting cancer cell proliferation. Its selectivity for specific mutations, such as T790M, makes it a preferred choice in advanced lung cancer therapies. The API’s production requires stringent adherence to quality and regulatory standards due to its application in life-saving medications.

Why India is a Key Player in Osimertinib Mesylate Production

India has emerged as a global leader in the API market due to its advanced infrastructure, cost-effective production capabilities, and adherence to international regulatory standards. Key factors contributing to India’s prominence include:

• Cost Efficiency: Indian manufacturers offer competitive pricing compared to other global markets.
• Regulatory Compliance: Many companies are approved by regulatory bodies like the USFDA, EMA, and WHO-GMP.
• R&D Capabilities: Indian companies invest significantly in research and development to optimize production processes and maintain high purity levels.
• Export Reach: Indian manufacturers have an extensive export network catering to markets in the US, Europe, and Southeast Asia.

Leading Osimertinib Mesylate Manufacturers in India

1. Cipla Limited

• Manufacturing Focus: Cipla employs advanced synthesis technologies to produce high-purity Osimertinib Mesylate. The company has a robust R&D setup for oncology APIs and implements green chemistry practices to ensure eco-friendly production.
• Certifications: WHO-GMP, USFDA, and EMA-approved facilities ensure global compliance.
• Export Specialties: Cipla’s strategic export operations focus on North America, Europe, and emerging markets, maintaining a strong supply chain for oncology products.

2. Dr. Reddy’s Laboratories

• Manufacturing Expertise: Dr. Reddy’s utilizes innovative chemical processes to manufacture Osimertinib Mesylate with optimal yield and purity. Its facilities are known for large-scale production capacity and adherence to strict quality protocols.
• Innovations: Focused on cost optimization and sustainability, their manufacturing integrates AI for enhanced process control.
• Global Reach: Active in over 100 countries, Dr. Reddy’s supports rapid delivery timelines and custom formulations.

3. Sun Pharmaceutical Industries

• Key Strengths: Sun Pharma has dedicated oncology API manufacturing units that specialize in targeted therapies like Osimertinib Mesylate. Their processes ensure minimal impurity profiles and regulatory compliance.
• Technological Edge: State-of-the-art production lines and real-time monitoring systems enhance efficiency.
• Market Position: Among the largest exporters of oncology APIs, with a significant market share in the US and Europe.

4. Aurobindo Pharma

• Production Techniques: Aurobindo uses advanced crystallization and purification methods to manufacture Osimertinib Mesylate, ensuring high stability and bioavailability.
• Compliance: Facilities certified by USFDA, TGA, and EMA make them a trusted partner for regulated markets.
• Export Dynamics: With a strong foothold in over 150 countries, Aurobindo offers competitive pricing and customizable API solutions.

5. Hetero Drugs

• Eco-Friendly Manufacturing: Hetero focuses on green chemistry techniques to reduce the environmental impact of Osimertinib Mesylate production.
• Capabilities: High-capacity units with automated systems for bulk API synthesis and precise quality control.
• Reputation: Known for cost-effective APIs with a commitment to meeting tight delivery schedules, Hetero serves clients across Southeast Asia, Africa, and Europe.

6. Anant Pharmaceuticals

• Manufacturing Focus: Anant Pharmaceuticals specializes in small-scale production of high-quality APIs like Osimertinib Mesylate, ensuring stringent quality control throughout the process.
• Certifications: WHO-GMP certified facilities with a focus on oncology-related APIs.
• Key Market Areas: Supplying to Southeast Asia and African markets, with a growing presence in regulated markets.
• Contact them: https://anantlabs.com/

7. Alembic Pharmaceuticals Limited

• Production Strength: Alembic boasts a legacy of API production, including targeted oncology APIs like Osimertinib Mesylate. They employ continuous process improvements for better yields.
• Certifications: USFDA, EMA, and WHO-GMP compliance.
• Global Outreach: Strong export network across Europe, North America, and Asia.

8. TAPI Technology & API Services

• Specialization: TAPI is renowned for advanced R&D and large-scale API manufacturing, including complex molecules like Osimertinib Mesylate.
• Technological Expertise: Employs state-of-the-art synthesis methods with a focus on sustainability.
• Market Presence: Dominates both regulated and unregulated markets worldwide.
• Contact them: https://tapi.com/

9. Bulat Pharmaceutical Pvt Ltd

• Capabilities: Focused on niche oncology APIs, Bulat Pharmaceuticals employs robust purification techniques for high-purity Osimertinib Mesylate and became one of the prominent Osimertinib Mesylate manufacturers in India.
• Certifications: GMP-certified facilities adhering to international quality standards.
• Market Focus: Expanding footprint in Middle East and South American markets.
• Contact them: https://bulatpharmaceutical.com/

The Manufacturing Process of Osimertinib Mesylate

The production of Osimertinib Mesylate involves advanced chemical synthesis techniques, ensuring high purity and stability. Key steps include:

1. Raw Material Sourcing: Procuring high-quality precursors.
2. Synthesis: Employing multi-step synthesis to achieve the desired molecular structure.
3. Purification: Using advanced filtration and crystallization methods to ensure high purity levels.
4. Quality Testing: Conducting stringent quality checks to meet international regulatory standards.

Regulatory Challenges and Opportunities

While India’s pharmaceutical industry thrives, manufacturers face challenges such as:

1. Intellectual Property (IP) Issues: Navigating patent laws and ensuring compliance.
2. Regulatory Hurdles: Meeting varying regulatory requirements for export markets.
3. Competition: Balancing cost-efficiency with quality in a competitive market.

Opportunities lie in expanding production capacities, investing in green chemistry techniques, and leveraging India’s cost advantage to dominate global markets.

Conclusion

Osimertinib Mesylate manufacturers in India are instrumental in addressing the rising global demand for this vital oncology API. Renowned companies like Cipla, Dr. Reddy’s, Sun Pharma, Aurobindo, Hetero Drugs, Anant Pharmaceuticals, Alembic Pharmaceuticals, TAPI Technology, and Bulat Pharmaceuticals are leading the way with cutting-edge technologies, strict regulatory compliance, and expansive global networks.

If you’re looking for reliable suppliers of Osimertinib Mesylate Manufacturers in India, Bulk Drugs Directory is your ultimate partner. We connect you directly with certified manufacturers, ensuring seamless access to high-quality APIs.

For inquiries or to collaborate, contact us today and let Bulk Drugs Directory be your trusted resource for all your API sourcing needs.