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Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation

Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation. Pharmaceuticals. Infrastructure. Engineering. Oil & Gas. Sandesara Group. Healthcare. Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals. Vision.

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Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation

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  1. Sterling Healthcare Limited ( A Sandesara Group Company)Company Presentation

  2. Pharmaceuticals Infrastructure Engineering Oil & Gas Sandesara Group Healthcare Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals

  3. Vision To become a global player in generic pharmaceutical business with: Supply of Quality Drugs Strategic Alliances Joint Ventures

  4. Plant Overview • Pharmaceutical Contract Manufacturing of Oral Solid Dosage Formulations (Tablet / Capsule / Granules) • Plot Size: 21,000 m² • Facility with built-up area of 5,077 m²

  5. Location Layout Mumbai Corporate Office Urse, Talegaon Sterling Healthcare Limited API Manufacturing Facility Baroda

  6. Site Layout

  7. Regulatory Status : • Audited & Approved by Germany (July 2013) • Audited & Approved by WHO, CDSCO (February 2012) • Audited & approved by MOH, Namibia (August 2010)

  8. Approvals WHO GMP Certificate EU GMP Certificate

  9. Approvals Republic of Namibia GMP Certificate

  10. Organogram

  11. Facility & Capacity • Two granulation suites (Approx. 219 Sq.m) • Two blending suites ( Approx. 47 Sq.m) • Four compression areas ( Approx. 130 Sq.m) • Two encapsulation areas ( Approx. 80 Sq.m) • Two coating areas (Approx. 124 sq.m) • Five packaging lines : 4 Blister and 1 Bulk Packing ( Approx. 134 sq.m)

  12. Tablet Manufacturing • Granulation : 1200 kg / shift ( 2 granulation suites) • Blending : 1680 kg / shift ( 2 blenders ) • Compression Machine • Coating Machine

  13. Capsule Manufacturing • Blending Octagonal blender • Encapsulation AF 90 T with latest features installed like Empty capsule sorter, Check weigher, Polisher, Filled Capsules and Metal detector

  14. Features of Formulation Plant • Individual processing areas serviced by dedicated AHU’s and differential pressure maintained to prevent cross – contamination • Tablets manufacturing areas : Temp. NMT 250 C and RH NMT 60% • Capsules manufacturing areas : Temp. NMT 250 C and RH NMT 45% • Manufacturing area classification complying to Grade D/Class 100,000. • HEPA filtered air is provided to Manufacturing areas. Total 36 numbers of AHUs, 05 Numbers of Dehumidifiers and 07 Numbers of Ventilation Units are provided in the HVAC system.

  15. Quality Systems All activities as per laid down SOPs and protocols Training program (Induction, Need based, Systems and Incident based) Batch manufacturing through controlled Batch Manufacturing records Deviation Management, Change Control Management and CAPA Use of approved and validated test procedures with controlled work sheets Investigation of Out of specification results Structured stability program Handling of Market complaint and Product recall Annual Product Quality Review Self Inspection Quality Risk Management

  16. Thank You !

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