Shilpa Pharma

Infrastructure

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State-of-the-Art Pilot & Manufacturing Facilities at Shilpa Pharma Lifesciences

At Shilpa Pharma, Our R&D teams help you with tailored solutions using phase appropriate development. We create value in each step of your program by inducting robust and economically viable processes, considering the future requirements. Due diligence is paid at the concept stage by executing a full phase process development prioritizing Safety, Solid stage studies to explore polymorph landscape, efficiency and sustainability. With an accumulated knowledge of more than 30 years, dealing with various chemistries, we meticulously plan experiments with a prime focus on Process design, development and delivery of NCE API across all clinical phases including IND enabling Tox batch. Additionally, we have acquired the ability to deal with Peptides, Polymers, ADCs, and Specialty chemicals.

Pilot Plant

Scaling from Gram to Kilogram

Our pilot plant is designed for seamless scale-up, enabling the transition from small-scale R&D batches to commercial production. With state-of-the-art reactors, controlled environments, and precision engineering, we ensure process optimization, reproducibility, and regulatory compliance. The facility supports new chemical entity (NCE) development, process validation, and technology transfer, allowing smooth commercialization.

Our pilot plant is equipped with a blend of SSR, GLR, CRYO reactors to deal both low and high temperature reactors. Using our miniature equipment, our scientist calibrates each rection by paying attention to pressure, exothermic, Input output ratios and minimizing byproducts to limit unknown impurities. Once the reaction is optimized, we will rope in our process engineering teams for proper reactor mapping ensuring smooth transition to manufacturing.

Process Safety

Our scientist has specialized knowledge and experience on various aspects of Drug Development and manufacturing. At Shilpa, our team will introspect the robustness of a developed route by identifying hazards, managing risks at an early stage, developing controls, evaluating and revising the conditions to make it safer and viable at plant scale. We treat every risk as an opportunity for further improvement by replacing or removing hazardous conditions and eliminating unsafe operations.  

Our team conducts a thorough investigation and continuously monitors the reaction kinetics and thermodynamics and generates data which would be useful for enhancing the conditions in a systematic manner. The data generated includes Minimum Ignition Energy (MIE), Minimum Ignition Temperature (MIT) and Dust Explosive Test (DET) and used in further investigation and risk assessment.

Manufacturing Plant

Shilpa Pharma offers integrated solutions, delivering exceptional value across the entire supply chain. Our state-of-the-art infrastructure enables us to meticulously design and execute the development and delivery of New Chemical Entities (NCEs) across all clinical phases. With a proven track record of successful regulatory audits, we are prepared to collaborate with our partners at any stage.
Leveraging our expertise and strong analytical support, Shilpa pharma ensure seamless delivery of KSMs, RSMs, advanced intermediates, and final APIs, while avoiding supply chain hurdles and uncompromising on quality and timelines.

Facilities

Shilpa Pharma operates two world-class manufacturing plants, Unit-1 and Unit-2, capable of handling both oncology and non-oncology drug substances. Our regulatory teams are adept at preparing the necessary documentation to support regulatory filings, including Investigational New Drug (IND) applications and New Drug Applications (NDA).

High-Containment Manufacturing for Oncology & Non-Oncology APIs
  • Dedicated Blocks: Multiple production suites for oncology and non-oncology molecules
  • Capacity Range: From low-volume (gram-scale) to large-scale (kilogram production)
  • Isolator Technology: Advanced containment with OEL Band 1-5 compliance
  • Specialized Infrastructure: Includes clean rooms, intermediate processing rooms, and HEPA filtration systems
Advanced Manufacturing for High-Potency & Specialized APIs
  • - High-potency manufacturing for HPAPIs, peptides, and specialty chemicals
  • - Dedicated processing suites with fully integrated analytical and quality control support
  • - Scalable production capacity for clinical and commercial supply
Both Unit-1 and Unit-2 are equipped with state-of-the-art analytical and quality control laboratories, ensuring regulatory compliance and product integrity. Our QC capabilities include:
  • Chromatographic Analysis: HPLC, UPLC, GC, and LC-MS for precise impurity profiling and quality testing
  • Structural & Solid-State Characterization: XRD, DSC, and spectroscopy for in-depth material analysis
  • Microbiology & Contamination Control: Dedicated microbiology labs for sterility and bioburden testing
  • Environmental Control: Clean rooms with HEPA filters ensuring contamination-free production
  • Stability Studies: ICH-compliant stability chambers for long-term and accelerated stability testing
Shilpa Pharma Lifesciences offers end-to-end peptide drug substance manufacturing, supported by specialized infrastructure for high-purity peptide synthesis. Our peptide purification and lyophilization capabilities include:
  • Lyophilizers: Designed for efficient drying and stabilization of peptides
  • Preparative Chromatography: High-performance HPLC and column purification systems ensuring high-yield and purity
To support large-scale production and supply chain security, we have a well-equipped warehouse with temperature-controlled storage solutions:
  • Cold Room Storage: Designed for temperature-sensitive materials, ensuring optimal stability and compliance
  • Strategic Inventory Management: Enables seamless production planning and uninterrupted supply