Square Pharmaceuticals Kenya

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Square Pharmaceuticals
Kenya EPZ Limited

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• Square Pharmaceuticals Kenya EPZ Ltd.
• A Formulation Manufacturing Facility for Oral Solid Dosages (OSD) in the form of Tablet and
Capsule in Phase 1
• Comply with Local Drugs Authority Kenya, Pharmacy & Poison Board (PPB) and International
Regulatory Requirements - WHO cGMP & PIC/s etc.
• Phase 2 – Oral Liquid Facility
• Phase 3 – Sterile (Injectables) Facility
• Square Pharmaceuticals Kenya EPZ Ltd to focus Africa & Other regulated markets.
PROJECT DESCRIPTION

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SQUARE PHARMACEUTICALS KENYA EPZ LTD.
“In Kenya, for Africa”
Description Details
Site Area 6.03 Hectare, 17 Acres, 6 EPZ Plots
Human Resources Employment Over 1,000, Phase 1 (Oral Solid Dosages - 500) Phase 2 (Oral
Liquids - 200) Phase 3 (Sterile - Injectables - 400)
Investment 75 M USD - Phase 1 (Oral Solid Dose – 25 M USD) Phase 2 (Liquids
10 M USD) Phase 3 (Sterile - Injectables 45 M USD)
Technology Transfer From US FDA, UK MHRA, ANVISA, SAHPRA compliant facilities of Square
Pharmaceuticals Limited, Bangladesh.
Aim Enhance local production of medicines reducing import
dependency & contribute Kenya economy

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SITE – 3D MODEL

5. cGMP FEATURES
• Material Air Lock (MAL) & Personal Air Lock (PAL) are provided for core process rooms to avoid cross-
contamination
• Viewer Corridor is provided for maximum visibility to avoid entry to process area
• Static & Dynamic Pass Boxes are introduced to transfer materials (i.e. clothes, sample, trash, machine parts
etc.)
• Low level return duct for HVAC (Heating Ventilation Air Conditioning)
• BMS (Building Management System) for HVAC control & EMS
• WIP (Wash in Place) facility for Granulation & Coating machinery
• Continuous Power Backup to Critical Appliances with UPS (Uninterruptible Power Supply)
• Clean room panels used for wall & ceiling & Epoxy floor for better hygiene
• Dedicated Air Handling Units for preventing cross contamination
• Closed material transfer with Bins & LPD (Lifting & Positioning Device)
• Environment, Health & Safety (EHS) compliance in machinery operation

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• Square Pharmaceuticals Kenya EPZ Ltd. ensures strict compliance with GMP
standards in every phase of manufacturing, testing and distribution of medicines.
• Square Pharmaceuticals Kenya EPZ Ltd. ensures all activities through a
documented Quality Management System (QMS) and continuously develops
Human Resources by regular training.
• Square Pharmaceuticals Kenya EPZ Ltd. undertakes appropriate review, evaluations
and performance measurement of its operations to assure compliance with the
established Quality Policy.
Quality Policy

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Site Signage

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Production Block

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Outside View

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Pipe racks

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LT Panels, UPS

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AHU

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AHU

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Chiller

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Oil Free Air Compressor, Drier & Receiver

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Purified Water System

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Purified Water System

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Epoxy & Panels

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Blender, Roller Compactor, Bin

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Granulation Machine

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Tablet Compression Machine 55/36 Stations

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Tablet Coating Machine, WIP, Water Scrubber

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Tablet Blister Machine

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Packing Hall

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Racks & PU Floor

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QC Lab

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QC Lab

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QC Lab

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Microbiology Lab

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Machinery/Operation Type No of Lines
Granulation Suites 2 (18 & 120 kg)
Vibro Sifter 1 (300 kg/hr)
Roller Compactor 1 (100 kg/hr)
Bin Blender 1 (15 - 360 kg)
Compression 2 ( 396,000 Tablet/Hr. & 172,800 Tablet/Hr.)
Coating 2 (36 & 320 kg)
Blister 2 (225, 225 Blister/min)
OSD – ORAL SOLID DOSAGES – MACHINE CAPACITY

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Sl. No. Product Name Generic Name
1 Angilock 50 Tablet Losartan Potassium USP
2 Deprex 10 Tablet Olanzapine EP
3 Deprex 5 Tablet Olanzapine EP
4 Melcam 15 Tablet Meloxicam EP
5 Melcam 7.5 Tablet Meloxicam EP
6 Protas 20 Tablet Esomeprazole 20 mg as Esomeprazole Magnesium Trihydrate USP
7 Protas 40 Tablet Esomeprazole 40 mg as Esomeprazole Magnesium Trihydrate USP
8 Remac 500 Tablet Clarithromycin EP
9 Square Zinc 20 Tablet Zinc 20 mg as Zinc Sulfate Monohydrate USP
10 Secnid DS Tablet Secnidazole INN
11 Zimax 500 Tablet Azithromycin 500 mg as Azithromycin Dihydrate EP
1st Phase Product List

32. OSD – ORAL SOLID DOSAGES
Tablets & Capsules Production Capacity(Million units/ Year)
Tablets 1200 Million
Capsules 300 Million (In-process)

33. Service Offer
•Products
•Private Labelling*
•CMO*
(* Not for sale in Kenya)

34. Contact Us
Email: intlmkt@squaregroup.com;
bulbul@squaregroup.com
Mobile: +8801713-067281

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