Shalin A
Shalin A
Shalin A
info@shalina.com www.shalina.com
22 November 2002
Shalina Laboratories
Todays Presentation
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Introduction Manufacturing Facility Liquid Orals Creams & Ointments Tablet Manufacturing Capsule Manufacturing Tablet & Capsule Packing Quality Control Quality Assurance Awards
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Introduction
1. Leading Health and Personal Care Company 2. Supplier of Pharmaceuticals, Personal Care products, Nutritional Supplements and Medical Devices 3. Successfully develops innovative products improve, enhance and extend human life that
4. Strength is delivering very high quality products at very affordable prices 5. Products are well accepted by medical professionals and consumers in the African Continent.
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Countries Exported
Angola Democratic Republic of Congo Ghana Nigeria Tanzania Zambia
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Dosage Forms
Topical preparations Capsules Tablets Oral Liquids Opthalmic preparations Injectabiles
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Therapeutic Segments
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Analgesic & Antipyretic Analgesic, Antipyretic & Antiinflammatory Anti-amoebic & Anti-protozoal Anti-asthmatics Antibiotics & Antibacterial Antidiarrhoeal Antifungal Antihistamine Antimalarial Antioxidant Antithelmintics Anti-tuberculosis Anti-ulcerant & Anti-flatulent 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. Appetizer Cough Syrup and Expectorant Eye & Ear drops Haematinics Nutrition & Vitamins Oral Rehydration Salts Tonics Topical Analgesic & cold balm Topical anti-allergic & Anti inflammatory Topical anti-fungal Topical Antiseptic & Antibiotic Tranquilizer Vaginal Tablets
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Manufacturing Facility
The Facility is: 9 9 9 9 Designed Constructed Adopted Maintained
WHO GMP STANDARDS 9 9 9 9 air- conditioned effectively ventilated proper Air Handling Units (AHUs) correct temperature & humidity
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Facilities
Water System: A validated water system for treatment of water. Wastage/ Disposal: Disposal of Solid, Liquid & Gas as per EPCB (Environment Pollution Control Board) Warehouse: Well designed to ensure good storage conditions. Sufficient & orderly warehousing of various categories of materials & products. Separate sampling area for Active Raw Materials & Excipients Separate area for Rejected, Recalled & Returned Material. Sampling & Dispensing of Sterile Material under aseptic condition.
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Liquid Orals
Shalina manufactures: Syrups, Suspensions, Oral Solutions Different therapeutic categories : Antibiotics, Antacids, Anthelmintics Analgesic, Antipyretics, Multivitamins etc Available in various pack sizes: 10ml, 30ml, 60ml, 100ml, 120ml, 200ml, 250ml
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Liquid Manufacturing
The manufacturing department is equipped with: Two 5000 litres capacity manufacturing tanks Three 3000 litres Capacity storage tanks One Colloid Mill with all Stainless Steel Fittings Output is around 5000 litres Per shift
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Shalina creams are available in 6gm, 15gm, 30gm & 50gm pack sizes
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Cream Manufacturing
The manufacturing department is equipped with: Two 1350 litres jacketed manufacturing tanks These are supported with Four 1350Ltr storage tanks
All together this gives a total output of 1000 kgs cream per shift.
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Tablets Manufacturing
SHALINA HAS A VERY GOOD TABLET MANUFACTURING FACILITY WITH AROUND 100 MILLION TABLETS CAPACITY PER MONTH We manufacture: 9 Uncoated tablets 9 Film coated tablets 9 Enteric coated tablets 9 Sugar coated tablets In Various Therapeutic Categories: 9 Analgesic 9 Antipyretics 9 Anti inflammatory 9 Anti Fungal 9 Anti Biotics etc.
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Tablet Granulation
This department has: 1. Sifting 2. Drying 3. Sizing facility Comprises of: 250 ltrs. Capacity rapid mixer granulator 120 kgs. Capacity fluidized bed drier 1250 ltrs. Octagonal blender All together gives output of 500 to 750 kgs granules per shift
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Tablet Compression
The compression department has: Single rotary compression machines Double rotary compression machines Both machines are 16, 23, 27, 35 & 45 station models
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Tablet Coating
The unique coating facility enables Shalina to get a good quality of film & sugar coated tablets. This department has: Three 48 coating pans. One 60 pan specially for sugar coating. Gives a total output of 3.0 million coated tablets per day.
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Capsule Manufacturing
Shalina has an excellent Capsule Manufacturing facility to manufacture Capsules of various sizes. Shalina manufactures capsules in sizes 0, 2 & 3. Shalinas product range in capsules covers the following Therapeutic Categories: 1. 2. 3. 4. Analgesic Anti-inflammatory Anti Biotics Multivitamins etc
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Capsule Blending
The capsule blending department has sifting & blending facility This comprises of 1250litres capacity Double Cone Blender This gives total output of 800kgs blends per shift.
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Capsule Filling
The capsule filling department is equipped: 1. 2. One Fully Automatic Capsule Filling machine Two Semi Automatic Capsule Filling machine
All together this gives an output of 1.0 million capsules per shift.
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Quality:
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Quality Control
This department ensures that materials are not released for use nor products released for sale or supply until their quality is judged to be excellent
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Quality Control
Different Departments: The Quality Control department has a separate section for: 1. 2. 3. Physico Analysis Chemical Analysis Microbiological Analysis
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Quality Control
Instrumentation Room: A separate instrumentation room Sophisticated instruments like: 1. UV Spectrophotometer 2. Infra Red Absorption 3. HPLC 4. GLC All instrumentation is provided and carefully maintained
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Quality Control
People: The testing of Raw Materials, Packing Materials & Finished Products are conducted by competent & highly technical staff
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Quality Assurance
9Ensures Pharma Products are designed & developed in conformity with the requirements of WHO GMP 9Separate Quality Assurance System
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Analytical reports
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Local Storage
High standards of local storage:
Palletisation Air Conditioning
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Awards
1. 2. 3. 4.
Ce r t ifica t e of M e r it from CHEMEXCI L in 1994 - 95 Ex ce lle nt Pe r for m a nce by CHEMEXCI L in 1995- 96 The N a t iona l Ex por t Aw a r d for Out st a nding Pe r for m a nce by The Governm ent of I ndia, in 1998- 99 The Tr ishul Aw a r d for Be st Pe r for m a nce from CHEMEXCI L in 1998- 99
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The National Export Award for Outstanding Performance by the Government of India on 8th May 2000
Award given by: Shree Atal Bihari Vajpayee, Prime Minister of India Award received by: Mr Shiraz Virji, Chairman of Shalina Laboratories
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