SPECIALIZED API OFFERINGS
The pharmaceutical industry is increasingly focused on specialty APIs that demand advanced technology, high containment, regulatory approvals, and scientific expertise. These include Highly Potent APIs (HPAPIs), hormonal APIs, controlled substances, and niche categories like iron colloids and macrolides.
At Lupin Manufacturing Solutions (LMS), we bring decades of Lupin’s global API leadership combined with specialized CDMO capabilities to deliver these challenging APIs safely, reliably, and compliantly. Our dedicated facilities, robust containment systems, and proven regulatory record make us a trusted partner for global innovators and generics companies alike.
HPAPIs (HIGH POTENCY APIs)
HPAPIs are central to modern therapies, especially in oncology, hormonal treatments, and targeted therapies. However, their extreme potency means they must be manufactured under strict containment and safety protocols. LMS has invested in dedicated HPAPI facilities with occupational exposure limits (OELs) <1 μg/m³, ensuring the highest standards of safety for employees, the environment, and product integrity.
Our Capabilities
- Dedicated HPAPI Suites: Engineered containment with negative pressure differentials, isolators, and airlocks
- Advanced Engineering Controls: Closed-system reactors, high-containment filtration, drying, and milling equipment
- Scalability: Supply from grams for preclinical programs to multi-kilogram batches for commercial needs
- Analytical Excellence: Potency testing, trace-level impurity detection, and cross contamination controls
- Regulatory Compliance: Facilities inspected by global regulatory bodies including USFDA, EMA, ANVISA, WHO
HORMONAL APIs
Hormonal APIs form the backbone of therapies in women’s health, endocrinology, and oncology. These APIs require dedicated facilities with stringent controls to prevent cross-contamination and ensure regulatory compliance. LMS operates specialized hormonal manufacturing units designed for estrogens, progestins, and other hormones, combining decades of Lupin’s expertise in hormonal therapies with CDMO flexibility.
Our Capabilities
- Dedicated Hormonal Facilities: Segregated units with independent HVAC and waste management
- Range of Hormonal APIs: Including estrogens, progestins, and androgen-related compounds
- Containment Systems: Specialized suites with isolators for safe handling
- Scale Range: Gram-to-commercial scale with validated processes
- Documentation: DMFs, CEPs, and eCTD-ready submissions for major markets
CONTROLLED SUBSTANCES
Overview
Manufacturing controlled substances requires not just technical expertise, but also compliance with global narcotics regulations (DEA, NDPS, EU directives, etc.). LMS is fully licensed and equipped to manufacture, store, and distribute controlled APIs responsibly. Our facilities and systems are audited and approved to handle Schedule II–V substances, enabling clients to advance projects without compliance risks.
Our Capabilities
- Licensed Facilities: Approved by DEA (US), NDPS (India), and compliant with global narcotics laws
- Security Infrastructure: Restricted access, 24/7 monitoring, controlled entry points, digital logs
- Product Range: Opiates, opioids, CNS-acting compounds, and related intermediates
- Documentation: Regulatory filings and quota management assistance
- Supply Chain Integrity: Secure distribution with tamper-proof logistics and GDP compliance
IRON COLLOIDS & MACROLIDES
Beyond standard APIs, LMS offers deep expertise in iron-based APIs and macrolides, categories that are technically challenging due to their complex synthesis, formulation interactions, and stability requirements. Iron colloids are critical in therapies for iron deficiency and anemia, while macrolides remain essential in antibiotics and immunosuppressants. LMS’s complex chemistry capabilities and analytical depth allow us to deliver these APIs with high purity, stability, and reproducibility.
Our Capabilities
- Iron Colloids: Manufacturing of stable colloidal dispersions with controlled particle size and bioavailability
- Macrolides: Expertise in multi-step, large-ring synthesis and complex fermentation-derived pathways
- Scale Range: Laboratory to full commercial production with validated impurity control strategies
- Analytical Strength: Stability testing under multiple stress conditions, impurity mapping, and polymorph characterization
