Sterling Healthcare Limited ( A Sandesara Group Company) Company Presentation 4/19/2017
Sandesara Group Pharmaceuticals Infrastructure Engineering Healthcare Oil & Gas Pharmaceuticals Sandesara Group Healthcare Business interests in: Healthcare, Oil & Gas, Infrastructure, Engineering, Pharmaceuticals 4/19/2017
Supply of Quality Drugs Strategic Alliances Joint Ventures Vision To become a global player in generic pharmaceutical business with: Supply of Quality Drugs Strategic Alliances Joint Ventures 4/19/2017
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 4/19/2017
Sterling Healthcare Limited Location Layout Mumbai Corporate Office Urse, Talegaon Sterling Healthcare Limited API Manufacturing Facility Baroda 4/19/2017
Site Layout 4/19/2017
Regulatory Status : Audited & Approved by Germany (July 2013) Audited & Approved by WHO, CDSCO (February 2012) Audited & approved by MOH, Namibia (August 2010) 4/19/2017
Approvals WHO GMP Certificate EU GMP Certificate 4/19/2017
Republic of Namibia GMP Certificate Approvals Republic of Namibia GMP Certificate 4/19/2017
Organogram 4/19/2017 Mr. Satish Shah CEO Mr.Sanjay Amla VP -Operations Mr.Laxman Gaddamwar DGM -Operations Mr. Bhaskar Joshi Manager -Production Execuive-04 Officer-04 Trainee-08 Technician-18 Mr. Prasanna Wagh Asst. Manager -Warehouse Executive-02 Mr. Sushim Jain Manager -Engineering Executive-01 Officer-02 Technician-07 Mr. Vilas Kharat Sr.Manager -HR Mrs. Chanda Peshave Sr. Manager-Accounts/Purchase Executive-04 Officer -02 Mr. Rajendra Nehete Sr.GM-Quality Mr. Manojkumar Sahu Head -QA Mr. Bhauso Vhanmane Asst. Manager-QA Execdutive-03 Officer-09 Trainee-03 Mr. Sikander Shaikh Sr. Executive -QC Executive-03 Officer-07 Trainee-06 Mr. Kedar Athalye Sr. Executive -Microbiology 4/19/2017
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) CAPACITIES Per month (Single Shift) (Million) Per annum Tablets 110 1300 Capsules 15 180 Blister Packing 65 780 Sachet Packing 0.33 3.6 4/19/2017
Tablet Manufacturing Granulation : 1200 kg / shift ( 2 granulation suites) Blending : 1680 kg / shift ( 2 blenders ) Compression Machine Coating Machine Equipment Capacity Make Rapid Mixer Granulator 180-480 Liters Saral Engineering Fluid Bed Drier 250 Kgs Fluid Bed Processor 500 Lts Pam-Glatt Compression Machine 37 Station 45 Station Legacy 61 station Cadpress IV 45 station with CFC 10-30 RPM 20-90 RPM 10-70RPM CIP Machinery Pam Pharmaceuticals Cadmach Machineries Auto coater 48 Inch 60 Inch 150 Kg 150-350 Kg Gansons Limited 4/19/2017
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 Equipment Capacity Make Capsule Filling Machine AF 90T 90000 Cap/Hr Pam Pharmaceutical Octagonal Blender 1250 L Global Pharmaceutical Equipment 4/19/2017
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. 4/19/2017
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 4/19/2017
Thank You ! 4/19/2017