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Wellborne pharma PPT by Mohammad Zubair.ppt
- 2. Manufacturing Facility: M/S. Wellborne Pharmachem & Biologicals Address: Plot No. 51/1, 52/2 Phase-ii, Industrial Estate, Hattar. Phone No. 0995617333 Email: Info@wellbornepharma.Com / Borne.Well@yahoo.Com Company Logo:
- 3. Details of Contact Persons Mr. Athar Niaz Rana CEO Phone No. 03215050600
- 4. DESCRIPTIONOF THE SITE Wellborne Pharmachem & Biologicals (Pvt.) Ltd Has Set Up The Pharmaceutical Manufacturing Facility At Plot No. 51/1, 52/2 Phase-ii, Industrial Estate, Hattar Total Area: 2 Acre Total Covered Area: 22000 Sq. Ft Production covered Area: 19380 Sq. Ft
- 11. LAYOUT PALN
- 12. LIST OF TECHNICAL STAFF S.NO . NAME DESIGNATION QUALIFICATION EXPERIENCE 1 Mr. Iftikhar Ahmad khan Plant Manager B. PHARM M.Phil 19 Years 2 Mr. Mohammad Zubair Production Manager Pharm.D M.Phil 13Years 3 Mr.Rehmat Zaman QC Manager Msc, Ph.D. 18Years 4 Mr. Khatir Khan Production Pharmacist Pharm. D 02 Years 4 Miss Zainab Microbiologist M.Phil Microbiology 01 Years 5 Mr. Adil shah QA Inspector B.Sc. 02 Years 6 M.Zain Qc Analyst Msc 03 Years 7 Mr. Mohammad Saqib Production Pharmacist Pharm. D 03 Years
- 13. TYPES OF PRODUCTS MANUFACTURED AT THE SITE The company has a number of registered products for both Sterile & Non Sterile Preparations in the following therapeutic range: Antibiotics Anti Malarial Anti Diabetics Cardiovascular Anti Psychotics Anti Allergic Anti Inflammatory Analgesics Anti Fungal Corticosteroids Anti Ulcers Anti Protozoal Anti helminthes
- 14. Dosage Forms Wellborne has well equipped manufacturing areas of the following dosage forms: Tablets Wet Injection Dry Injection Lyophilized Dry Syrup Capsule Dry Injections
- 15. APPROVED SECTIONS Tablets(General) Wet Injection(General) Dry Injection Lyophilized(General ) Capsule General Dry Syrup Cephalosporin Capsule Cephalosporin Dry Injections Cephalosporin
- 16. Quality Moto WELLBORNE’s mission is to bring value to the patients and customers through its innovative, high quality products, which improves sustain or restore health. As ethically, socially and ecologically responsible organization, WELLBORNE places premium dealing fairly with employees, commercial partners, Government authorities and public, success in its business ventures depends upon maintaining the trust of these essential stakeholders.
- 17. Flow Charts of Production
- 18. FLOW CHART OF TABLET SECTION Issue Requisition Issue Requisition PRODUCTION DEPARTMENT RAW MATERIAL STORE PACKING MATERIAL STORE Sorting (Packing Material) QA Line Clearance MIXING LUBRICATION QA/QC Sorting (Tablets) QA Line Clearance PACKING Finished Goods Store Retained Sample Blistering Sorting/ (Blisters) QA Line Clearanc e QA Line Clearance GRANULATION DRYING GRANULATION COMPRESSION COATING QA/QC QA/QC
- 19. FLOW CHART OF CAPSULE SECTION PRODUCTION DEPARTMENT RAW MATERIAL STORE PACKING MATERIAL STORE Sorting (Packing Material) QA Line Clearance MIXING LUBRICATION QA/QC Sorting/Polishing QA Line Clearance PACKING Finished Goods Store Retained Sample Blistering Sorting/(Blisters) QA Line Clearan ce QA Line Clearance
- 20. FLOW CHART OF DRY SUSPENSION SECTION (CEPH) Issue Issue Requisition (M.O) Requisition (P.O) PRODUCTION DEPARTMENT RAW MATERIAL STORE PACKING MATERIAL STORE PRINTING QA Line Clearanc e SIEVING QA Line Clearanc e MIXING FILLING SEALING QA/QC LABELING QA Line Clearanc e PACKING Finished Goods Store Retained Sample
- 21. FLOW CHART OF LIQUID INJECTION Issue Requisition Issue Requisition PRODUCTION DEPARTMENT RAW MATERIAL STORE PACKING MATERIAL STORE PRINTING QA Line Clearanc e WASHING QA Line Clearanc e MIXING FILLING OPTICAL CHECK QA/QC LABELING QA Line Clearanc e PACKING Finished Goods Store Retained Sample QA Line Clearanc e DRY HEAT STERILIZATION AUTOCLAVATION FILTERATION
- 22. FLOW CHART OF DRY INJECTION CEPH Issue Requisition Issue Requisition PROCUCTION DEPARTMENT Raw Material Store Racking Material Store FILLING PRINTING QA Line Clearanc e LABELING SEALING PACKING Finished Goods Store Retained Samples QA Line Clearanc e QA Line Clearanc e QA/QC
- 23. LIST OF CRITICAL EQUIPMENT IN PRODUCTION DEPARTMENTS CEPHALOSPORIN (STERILE) S.No Equipment Name Type & Capacity Identification 1 Ambica Filling Machine 36000/8 Hrs. INDIA 2 Vial Sealing Machine 72000/ 8 Hrs. CHINA 3 LFH Fitted Trolley 6-Trays/ Load. LOCAL 4 Dry Heat Sterilizer 16000 Vials/ Load. LOCAL 5 Autoclave 18/36” LOCAL 6 Vial Washing Machine 20000/ 8 Hrs. LOCAL
- 24. CEPHALOSPORIN CAPSULE FILLING LINE Sr.# Equipment Name Type & Capacity Identification 1 Double Cone Mixer 100kg LOCAL 2 Semi- Automatic Capsule Filling Machine 10000/ Hrs CHINA 3 Capsule Sorting Machine 100000/ 8 Hrs. IMPORTED
- 25. CEPHALOSPORIN POWDER FILLING LINE Sr.# Equipment Name Type & Capacity Identification 1 Sugar Crushing Machine 200kg/ Hr. LOCAL 2 Cone Mixer S.S 100kg DO 3 Dry Powder Filling Machine 8500/ 8 Hrs DO 4 Bottle Sealing Machine 9000/ 8 Hrs. DO 5 Bottle Blowing Machine As per requirement DO 6 Tray Dryer 30 Trays DO
- 26. General Capsule Filling Line Sr.# Equipment Name Type & Capacity Identification 1 Semi-Automatic Capsule Filling Machine 10000/ Hrs CHINA
- 27. GENERAL TABLET SECTION. Sr.# Equipment Name Type & Capacity Identification 1 Ribbon Mixer 100Kg LOCAL 2 Double Cone Mixer 100Kg LOCAL 3 Rotary Granulator 100Kg LOCAL 4 Oscillating Granulator 50Kg LOCAL 5 Fluid Bed Dryer 30Kg/Local LOCAL 6 Tray Dryer 100Kg LOCAL 7 Tablet Compression Machine vZP-17 25000 Tabs/Hr. CHINA 8 Coating Pan-1 50Kg LOCAL 9 Coating Pan-2 10Kg LOCAL 10 Alu-Alu Blistering Machine -1 30 Strokes/min CHINA 11 Solution Mixer 20 L LOCAL
- 28. LYOPHOLIZED SECION Sr.# Equipment Name Type & Capacity Identification 1 Manual Filling Machine 20000/ 8 Hrs. LOCAL 2 Manual Sealing Machine 6500/ 8 Hrs. LOCAL 3 LFH Fitted Trolley 6-Trays/ Load LOCAL 4 Dry Heat Sterilizer 20000 Vials/Load LOCAL 5 Autoclave 36/48” LOCAL 6 Vial Washing Machine 15000/ 8 Hrs LOCAL
- 29. LIQUID INJECTION SECION. Sr.# Equipment Name Type & Capacity Identification 1 Formulation Tank -1 50 L LOCAL 2 Formulation Tank -2 250 L LOCAL 3 Propeller 300 rev/min. LOCAL 4 Filtration Assembly As per requirement LOCAL 4 Pyrex Glass jar 2x20 L ENGLAND 5 Dry Heat Sterilizer 50000 Amp/Load LOCAL 6 Autoclave 18/36” LOCAL 7 Ampoule Washing Machine 50000/ 8 Hrs LOCAL 8 4.Head Ampoule Filling Machine 40000/ 8 Hrs CHINA
- 35. ALU-PVC BLISTER MACHINE FOR CEPH AREA
- 36. ALU-PVC Blister Machine for General area
- 37. AMBICA VIAL FILLING MACHINE
- 38. LABEL AND UNIT CARTON PRINTING MACHINE
- 40. CONE MIXER
- 44. DRY GRAULATOR
- 45. TRAY DRYER
- 46. WET GRANULATOR
- 47. RIBBON MIXER
- 48. ZP 17 COMPRESSION MACHINE
- 50. SUGAR CRUSHER
- 52. AMPOULE /VIAL WASHING MACHINE
- 53. RO & DISTILATION PLANT
- 54. LABEL PRINTER
- 56. S.No. Title Model Serial No. Manufacturer 1 High Performance Liquid Chromatography Pump: LC 210 Detector: LC 220 PG Instrument 2 Fourier Transform Infra-Red Spectrometer Hazmalt ID, USA 017881106G Smith USA 3 UV/Visible Spectrophotometer UV/VIS China 4 Liquid Particle Counter Z1 AN4035 Beckman 5 Total Organic carbon Analyzer Sievers 800 05209 Sievers 6 Analytical Balance AUX-220 D-449517180 Shimadzu 7 Dissolution Test Apparatus-Distek Distek 2100 A Distek 8 Dissolution test Apparatus-Galvano GDT-6L Galvano 9 Disintegration test Apparatus 122-LR Galvano 10 pH meter 3863 Beckman 11 Conductivity Meter 3010M JCO1738 Jenco 12 Total Dissolved Solid Meter TDS-3/1201 1408832 China 13 Polarimeter ABBE Manual 0-179 ABBE 14 Refractometer 131537 ABBE 15 Friabilator FT-L Galvano
- 57. 16 Hardness Tester MH-1 Galvano 17 Melting Point Apparatus GMP-L1 China 18 Stability Chamber-Hotpack Hot Pack AR11BMS1005 HEICO 19 Stability Chamber-450 L MEC 450 CUC45060905170015 611 United Technologies 20 Stability Chamber-80 L 100 LC United Technologies 21 Reference Standard Cabinet Sanpla 75318 Sanpla Tech Corporation 22 Drying Oven DHG-9030A 23 Ultrasonic Bath GS2D120 0501024823008 Greatsonic China 24 Hot Plate with magnetic Stirrer DHPS-1 Galvano Scientific 25 Vernier Caliper Digital 0-150mm China SH 26 Screw Gauge Digital 0-25mm China 27 Vacuum Pump AS20 GS 28 Fridge 9175WB Monoplus 033373 Dawlance 29 Thermometer Zeal Nil Local 30 Data Logger (Accelerated)
- 58. 31 Data Logger (On- Going) 32 Data Logger (Inst. Room) 33 Digital Lux Meter AS803 Smart Sensor 34 Laser Particle Counter 273B-3-1-1CE Met One 35 Colony Counter 3327 10360-9 QuBecDarkfield Reichert Jung USA 36 Microscope Electronic 37 Digital Anemometer AS816 Smart Sensor 38 Vortex Meter 39 Micropipette 100ul- 1000ul YL174AB0011080 Accumax 40 Micropipette10ul- 100ul Diamet 41 Micro Air Sampler UK by FW 42 Hot Incubator MS07484 11211591 Forma Scientific 43 Cold Incubator SPX-150 Bio chemical culturing Box 44 Autoclave Local 45 TDS TDS-3 46 Data Logger (On- Going)
- 66. HVAC EQUIPMENTS S.NO AHU LOCATION CAPACITY 1 AHU-1 MICRO LAB 4ton(1600cfm) 2 AHU-2 INJECTION WASHING 4ton(1600cfm) 3 AHU-3 LIQUID INJECTION 6ton(2400cfm) 4 AHU-4 LIQUID INJECTION SOLUTION PREPARATION 4ton(1600cfm) 5 AHU-5 LYPHOLIZATION 4ton(1600cfm) 6 AHU-6 GENERAL TABLET 8ton(3200cfm) 7 AHU-7 Dry vial Injection 6ton(2400cfm) 8 AHU-8 Cephalosporin Capsule 4ton(1600cfm) 9 AHU-7 Cephalosporin Dry Vial 6ton(2400cfm)
- 67. HVAC PICTURE
- 68. Ro water ,Distillation Plant and Air Utility S.No Equipment Capacity Small Compressor 6 Bar Large Compressor 8Bar Distillation Plant 60L/H RO Plant 2000L/H
- 69. APPROVED PRODUCTS TABLETS 97 CAPSULE 27 DRY SUSPENSION 09 AMPOULES/IV INFUSION 19 DRY INJECTION 23 TOTAL PRODUCTS 175
- 70. Capsule Dosage form S.N o Brand Name Strength Pack Size Registration No 1 Cefatek 250 mg 2*6's 81217 2 500 mg 12's 81216 3 Cefratek 250 mg 12's 81224 4 Lxib 100 mg 4*5's 81214 5 Mycotek 150 mg 1's 81215 6 Aztek 250 mg 1x6's's 81225 6 10's 7 Bromep 20 mg 2*7's 54964 8 Adrox 500 mg 12's 81219 9 250mg 10's 81218 10 Zumax 400 mg 1*5's 54899 11 Dlx 60 mg 10's 95988 11 14's 95988 11 28's 95988 11 30's 95988
- 71. Capsule Dosage form S.No Brand Name Strength Pack Size Registration No 12 Esoborn 20mg 2*7's 54962 13 40mg 2*7's 54963 14 Abenaki 300mg 14's 86478 15 Abenaki 150mg 1x10's 86477 16 Abenaki 100mg 1x10's 86476 17 Abenaki 50mg 10'S 96160 17 14'S 18 Abenaki 20'S 96160 18 19 Tramine 500mg 20's 96999 20 Fas Fotek 500mg 10's 97000 21 Zpras 40mg 14's 81213 22 Zpras 60mg 2x10's 81212
- 72. Capsule Dosage form S.No Brand Name Strength Pack Size Registration No 23 Dlx 20mg 10's 95989 23 Dlx 20mg 14's 95989 23 Dlx 20mg 28's 95989 23 Dlx 20mg 30's 95989 24 Dlx 30mg 10's 95990 25 Dlx 30mg 14's 95990 25 Dlx 30mg 28's 95990 25 Dlx 30mg 30's 95990 26 Xtab 250mg 12's 81747 26 Xtab 500mg 12's 81748
- 73. DRY SUSPENSION S.No Brand Name Strength Pack Size Registration No 1 Cefatek 125mg/5ml 60 ml 81222 2 250mg/5ml 81223 3 Xtab 250mg/5ml 60ml 81749 4 125mg/5ml 81750 5 Predox 40mg/5ml 50ml 93629 6 Adrox 125mg/5ml 60 ml 81220 7 250mg/5ml 81221 8 Zumax 100mg/5ml 30 ml 54897 9 200mg/5ml 30ml 54898
- 74. TABLETS S.No Brand Name Strength Pack Size Registration No 1 Meloxicam 7.5mg 1x10's 54870 2 15mg 1x10's 54871 3 Levesulpiride 25mg 2x10's 54872 4 50mg 2x10's 54873 5 Loratidine 10mg 1*10's 83877 6 Ciprofloxacin 250mg 1*10's 54901 7 Ciprofloxacin 500mg 1*10's 54900 8 Clarithromycin 250mg 1*10's 82617 9 Clarithromycin 500mg 1*10's 82618 10 Fexofenadine 60mg 10's 83878 11 120mg 10's 83879 12 180mg 10's 83880
- 75. Tablet S.No Brand Name Strength Pack Size Registration No 13 Diclobron-K 50mg 20's 54908 14 Feforn 100mg 1x10's 54876 3x10's 15 Le-One 250 mg 1*10's 54874 16 Le-One 500 mg 1*10's 54875 17 Proart Plus 40mg+240mg 1*8's 54909 18 Ikast-10 10mg 14's 83883 19 Mecoborn 0.5mg 3x10's 54877 2*10's 20 Zinzan 2mg 1*10's 80864 21 4mg 1*10's 80865 22 B-Panta 40mg 2x10's 54906
- 76. Tablet S.No Brand Name Strength Pack Size Registration No 23 Naxpro 250mg 2*10's 54880 24 Naxpro 500mg 2*10's 80866 25 Feforn Plus 100+0.35mg 1*10's 3x10's 56829 26 Deborn 50mg 2*10's 54911 27 Citowel 10mg 2x15's 14's 80868 28 Moxox 400 mg 1*5's 95181 29 Titek 10mg 1*10's 95182 30 20mg 1*10's 95183 31 40mg 10's 78506 32 Destidine 5mg 1*10's 54880
- 77. Tablet S.No Brand Name Strength Pack Size Registration No 33 P-Beta 20mg 2*10's 54878 34 Letrin 5mg 1*10's 54910 35 Reborn 400mg 1*10's 54913 36 Mycophenol 500mg 10's 77412 2x10's 5x10's 37 Ifaxim 200mg 1x10's 80867 38 Olazap 5mg 10's 80869 39 10mg 10's 80870 40 Rosutate 10mg 10's 95184 41 Rovustat 5mg 10's 80871 42 Rosutate 20mg 10's 95185
- 78. Tablet S.No Brand Name Strength Pack Size Registration No 43 Tegaserod as Hydrogen Maleate 6mg 3x10's 80872 44 Vildagliptin 50mg 10's 80908 45 Quetiapine as fumarate 25mg 3x10's 81205 46 100mg 10's 81205 47 Candesartan Cilexetil 16mg 28's 81207 48 4mg 14's 81210 49 8mg 14's 81211 50 Risedronate Sodium as Hemipenta Hydrate 5mg 10's 81208 51 Acyclovir 800mg 2x10's 81209 52 Talbivudine 600mg 28's 83881 53 Chlorpheniramine Maleate 4mg 10x100's 83882 54 Vildagliptin + Metformin Hydrochloride 50/850mg 14's 88557 55 28's
- 79. Tablet S.No Brand Name Strength Pack Size Registration No 57 Dagmet 50/1000mg 14's 87014 28's 58 Virastep 0.5mg 3x10's 87015 59 1.0mg 3x10's 87016 60 Meem 1.0mg 2x10's 88700 61 2.0mg 2x10's 88701 62 3.0mg 2x10's 88702 63 4.0mg 2x10's 88703 64 Sitanec 50/500mg 1x10's 89773 65 Sitanec 400mg 100's 89774 66 Wellzol 325/337.5mg 10's 90718 67 Temd 2.5mg 1's 90722 68 Zolweb 30's 90725 1x10's
- 80. Tablet S.N o Brand Name Strength Pack Size Registration No 69 Bonema 35mg 4's 91358 70 Solben 50mg 1x10's 94694 71 Navajao 8mg 10's 95099 72 Navajao 4mg 10's 95098 73 Catraz 150mg 5x10's 82619 74 300mg 1's 82620 75 600mg 1's 82621 76 Linzotek 600mg 12's 96159 77 Lotiox 8mg 10's 96162 78 Sindolar SR 50mg 10's 94737 79 Wellverin 135mg 13's 96889 80 Epritek 50mg 2x10's 96292
- 81. Tablet S.No Brand Name Strength Pack Size Registration No 81 Amvazide 10/160/12.5mg 14's and 28's 87436 82 Amvazide 5/160/12.5mg 14's and 28's 87437 83 Amvazide 10/160/25mg 14's and 28's 87438 84 Amvazide 5/160/25 14's and 28's 87439 85 Amvazide 10/320/25mg 14's and 28's 87440
- 82. AMPOULES/ I.V INFUSION S.No Brand Name Strength Pack Size Registration No 1 W-Borne 5ml 5mlx1's 78422 2 Chloroton 0.9% 5ml 5mlx1's 98791 3 Amikar 100mg 2mlx1's 005726-Ex 4 B-Genta 80mg 2mlx5's 54893 5 Ceprotek 200mg 100mlx1's 54904 6 Le-One 500mg 100mlx1's 54886 7 Deborn-L 75mg 2ml*1'S 54907 8 Deborne 75mg 3mlx5's 56828 9 Bropox 5ml 20mg 54912 10 Fero Dry Injection 5ml 100 mg 78505 11 B.Metho 100mg 100mg 54884
- 83. AMPOULES/ I.V INFUSION S.No Brand Name Strength Pack Size Registration No 12 Nofiver 30 mg 1 ml*5's 94693 13 Hytran 250 mg 5 ml*10's 14 Wellzol 500mg 100mlx1's 90724 15 Navajao 8mg 4mlx5's 97176 16 Moxox 400mg 250ml x1's 90721 17 Proart 80 mg 1 ml*5's 54896 18 Mecoborn 0.5 mg 1 ml*10's 54885 19 D-Well 5 mg 1 ml*5's 77411 5 mg 1 ml*1's
- 84. DRY INJECTION S.No Brand Name Strength Pack Size Registration No 1 Cefpam 500 mg 1's vial 54882 2 1gm 54883 3 Brocifen 250 mg 1's vial 54902 4 500 mg 54903 5 1gm 54905 6 CT-X 500mg 1's vial 93274 7 250mg 93275 8 93276 9 Neocef 250mg 1's vial 93352 10 500 mg 93351 11 1 g 93350 12 Sulbron 1g + 1 mg 1's vial 54889 13 500 mg + 500 mg 54888
- 85. DRY INJECTION S.No Brand Name Strength Pack Size Registration No 14 Esoborn 40mg 1's Vial 54881 15 Bromep 40mg 1's Vial 54887 16 Taczin 250mg 1's Vial 54890 17 500mg 54891 18 1gm 54892 19 B-Panta 40mg 1's Vial 54895 20 Finto 250mg 1's Vial 90719 21 500mg 90720 22 1000mg 90723
- 86. DML 000657
- 87. cGMP CERTIFICATE
- 88. ISO CERTIFICATE
- 91. FUTURE PLANING WELLBORNE FUTURE PANNING IS TO ESTABLISH AND DEVELOP FOUR NEW SECTIONS IN A ALREADY BIOLOGICALS SECTION LAYOUT. The NEW SECTION NAME ARE 1.TABLET (PSYCHOTROPIC) SECTION 2. SOFT GEL CAPSULE SECTION 3. CREAM/OINTMENT GEL (GENERAL) 4.OPTHALMIC STERILE DROPS (GENERAL) THE LAYOUT OF FOUR NEW SECTION IS UNDER APPROVAL STAGES. NEW MACHINES FOR ABOVE MENTIONED SECTIONS ARE IMPORTED FROM CHINA.