Commercial Manufacturing
The present day technological exclusive current good manufacturing practices (cGMP) and manufacturing capabilities have to scale-up the manufacturing from laboratory volume to the commercial levels. A phase-appropriate manufacturing philosophy in our facilities, which are compliant with the regulatory guidelines is followed. A demonstrated capabilities and experience to manufacture batches of small molecule drug substances, advanced intermediates as well as regulatory starting materials for pre-clinical, clinical, and commercial applications at appropriate facilities, and are further expanding our capabilities to cater to growing demand from global innovators in both pharma (Human Health & Animal Health) as well as non-pharma industries.
All our scale-up activities are performed by an experienced team of chemical manufacturing personnel operating 24×7. The team is well-supported by other functions such as quality control, quality assurance, environment health safety and sustainability, engineering and maintenance, and supply chain management. The uncompromised commitment to safety and regulatory compliance has made us trusted partners of several global customers.
Infrastructure
A dedicated state-of-the-art cGMP manufacturing facilities support the small molecules contract manufacturing business. Since inception, we supply clinical (early & late phase) as well as commercial drug substances (NCEs), advanced intermediates, regulatory starting materials and select generic APIs.
The facility includes equipment of various capacities and materials of construction operating over a wide range of temperatures. We comply that facility can produce an output from grams to hundreds of kilograms per batch of materials for various projects.
A dedicated HPAPI cGMP manufacturing facility will facilitate to handle cytotoxic and cytostatic high potent compounds. The facility includes multiple reactors and downstream equipment, which are housed in standard isolators, to support output/batch.
The team of highly qualified and experienced technicians operate the facilities in compliance with all safety and regulatory requirements. With a strong emphasis on maintaining quality as well as ensuring the safety of man and material at every stage, all the necessary support functions such as environment, health, and safety (EHS), and maintenance are available on-site.
State-Of-The-Art Equipment
The manufacturing facilities have different ISO certified clean rooms that are segregated into wet and dry processing areas. The wet processing area includes various-sized reactors made of glass, SS314, and Hastelloy, that are controlled through a validated distributed control system (DCS). It also has various Nutsche filters, centrifuges, sparkler filters, and dryers. The dry processing area handles all powder processing and is equipped with the necessary drying, milling, sifting, and packing equipment.
The facilities can handle both dry and wet milling operations, reducing particle size to as low as required. A different dryer equipment such as vacuum tray dryers, rotary cone vacuum dryers, and spray dryers. Our milling units include multi mill, pin mill, and wet mill units.
Testing of raw material, in process and finished product related to production is performed at the GMP Quality control laboratories and QC-Microbiology laboratories. We perform both normal-phase and reverse-phase high-performance liquid chromatography (HPLC) purification and separation using Novasep and other chromatographic systems (SS316L and glass columns) in a classified area. We handle cryogenic reactions with temperatures as low as -100°C using different scales and reactors made of SS316L and Hastelloy. Our hydrogenation reactions are also performed in a classified zone to meet various process conditions, volumes ranging from 600 L to 4000 L operating under the pressure up to 20 Barr.
World-class facilities for contract manufacturing capabilities
- Reactor volumes are fully efficient.
- At site, the slots for additional volumes are fully ready with the sufficient utility support already available on-site.
- Range of small- & large-scale cryogenic reactors.
- Hastelloy hydrogenators ranges(Operating pressure of 20 bar).
- High vacuum (< 10 Torr) & high temperature (140°C) distillations.
- HPAPI cGMP manufacturing facility to handle cytotoxic and cytostatic high potent compounds up to 0.1 µg/m³-8hr.
Operational Excellence
- Safety , Quality, Delivery, Engagement, Cost, Compliance
Strategic Sourcing
- In alignment with PPIC (Project Planning & Inventory Control)
Culture of safety and accountability (EHSS)
- The manufacturing sites will be zero liquid discharge facilities.
- In commercial manufacturing site, after initial neutralization, the effluent treatment happens on off-site facility located away from on-site facility.
Sustainability
- Energy, Water, Waste management. CSR & Governance
Quality Management System
- Well established