SlideShare a Scribd company logo
1
Square Pharmaceuticals
Kenya EPZ Limited
2
• 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
3
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
4
SITE – 3D MODEL
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
6
• 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
7
Site Signage
8
Production Block
9
Outside View
10
Pipe racks
11
LT Panels, UPS
12
AHU
13
AHU
14
Chiller
15
Oil Free Air Compressor, Drier & Receiver
16
Purified Water System
17
Purified Water System
18
Epoxy & Panels
19
Blender, Roller Compactor, Bin
20
Granulation Machine
21
Tablet Compression Machine 55/36 Stations
22
Tablet Coating Machine, WIP, Water Scrubber
23
Tablet Blister Machine
24
Packing Hall
25
Racks & PU Floor
26
QC Lab
27
QC Lab
28
QC Lab
29
Microbiology Lab
30
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
31
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
OSD – ORAL SOLID DOSAGES
Tablets & Capsules Production Capacity(Million units/ Year)
Tablets 1200 Million
Capsules 300 Million (In-process)
Service Offer
•Products
•Private Labelling*
•CMO*
(* Not for sale in Kenya)
Contact Us
Email: intlmkt@squaregroup.com;
bulbul@squaregroup.com
Mobile: +8801713-067281
35

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SPL-EPZ-Kenya PPT_06-Jun-2023.pptx

  • 2. 2 • 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
  • 3. 3 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
  • 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
  • 6. 6 • 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
  • 15. 15 Oil Free Air Compressor, Drier & Receiver
  • 22. 22 Tablet Coating Machine, WIP, Water Scrubber
  • 25. 25 Racks & PU Floor
  • 30. 30 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
  • 31. 31 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)
  • 35. 35