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FINISHED DOSAGE FORMS FACILITY

Our formulation manufacturing facility is located in Aurangabad, India, and is benchmarked to the highest international quality standards. With state-of-the-art manufacturing facilities, we aim to be one of the most valued integrated Pharmaceutical Companies offering end-to-end solutions for CMO and New product developments.

Our key focus is on the core segments of lifestyle therapies such as Anti-Diabetics, Antihypertensives, CNS acting drugs, Gastrointestinals, Anti-gouts etc. We have a capacity of 2 Billion tablets per annum with full automation controls in multiple phases offering batch sizes with respect to granulation capacity up to 4000 kg per batch. Additionally, 8 Billion tablets capacity facility is under completion and will be operational by Q4 2021.

We also have a completely dedicated small-batch manufacturing area (SBM) for low volume niche products offering batch sizes with respect to granulation capacity as 11 kg to 33.5 kg.

Our facility is EU GMP and TGA approved. USFDA audit has been triggered.

Key Highlights of our Formulation facility

  • he facilities are benchmarked to the highest international quality standards.
  • World-class technology – Vertical process flow by gravity.
  • Fully automated high-speed machines (Fette for compression, Uhlmann for blister packing, CVC & IMA for bottle packing, Glatt & Innojet for coating)
  • Fully integrated track and trace system to meet stringent regulatory requirements.
  • Separate man–material entry with access controls.
  • Material handling system by Matcon to avoid Human touch interference.
  • ‘Wash-in-place’ system for cleaning the equipment.
  • COSA – Tablet inspection machine for 100% check of tablets before packing.

Research & Development – the backbone of our finished dosages business

We have a renowned and fully equipped R&D facility at Aurangabad utilizing the latest laboratory equipment compliant to 21-CFR. We have a highly skilled and experienced team of scientists for developing generic equivalents and complex products in-house.

Key Highlights of our R&D

  • Focused on the development of generic formulation in all therapeutic areas mainly Diabetes, CVS, CNS, and other lifestyle therapies.
  • Well-versed with developing the products using the QbD approach and capable of handling FTF Projects.
  • Expertise in the development of Immediate Release, Modified release (Matrix & Reservoir), Orally disintegrating, and Chewable Oral Solid Dosage Forms.
  • Well-versed with Pelletization technology (Fluid bed system – Innojet and Glatt).

Lab Facility

  • Lab-scale setup from 3 L to 13 L for wet granulation. For pellets 0.5 kg – 1.8 kg.
  • Advanced pellet coating facility with Bottom spray (Glatt wruster and Innojet) 2.5 kg line Lab scale, 25 kg line Pilot, and 800 Kg at commercial scale.
  • For Pilot Bio Batches, dedicated GMP area of 25.0 kg capacity for tablets, capsules as well as pellets.

Our new and futuristic R&D center, in Navi Mumbai, further augments our innovative programs for enhanced production.

Formulation Business Models

  • Contract Manufacturing
  • Co-development/ Development

We have been associated with big generic companies for offering the best to end-users and stakeholders. We work in close coordination with our customers for leveraging core competencies. Many new projects for Finished Dosage are under various stages of development & regulatory submissions.