krux pharma pvt ltd
TRANSCRIPT
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MR. IMRAN SIROHAManaging Director
+91 9925550044
MR. SANJIV PATILPlant Head
+91 9823589497
Dr. D. J. ZawarGroup Chairman
+91 9673338586
MR. PARESH PARMARQuality Head of Group Company
+91 9823561880
MISSION
VISION
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SITE AREA
Sr. No. Area NameApproximate area in
2m
01 Total site area 2486.81
02 Warehouse 909.71
03 Production 1137.54
04 Quality Control 284.21
05 Quality Assurance 119.30
06 Administration 79.46
07 Utilities 223.32
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Primary Settling - Organic / Inorganic chemical separation
Aeration- Biomass degradation takes place in presence of bacteria & oxygen.
Secondary Settling - Separation of addition suspended solid & biomass take place.
Mixed Bed - color / Odour removal, Oil & grease separator
ETP outlet Water used for Gardening.
ETP WITH ZERO DISCHARGE
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Capability of manufacturing different Finished Dosage form such as: Tablets, Capsules and Dry Syrup.
Dedicated state-of-art manufacturing equipment such as compression machine, RCVD, Blenders, Tray Dryer, Dry Syrup line, capsule filling machine.
4 dedicated packing lines Viz Alu – Alu Blister, Alu – PVC blister Strip Packing Bottle filling
Production capacities (Single shift (8hr) basis) Tablets – 5,00,000 Tablets Capsules – 10,00,000 Capsules Dry Syrups – 48000 Bottles of Size (60 ml,100 ml)
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Pretreatment Water System 1700 LPH
Purified Water System generation 500 LPH
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Compressed Air
Make- CPType- Reciprocating type.Capacity- 223 CFM.Dew Point -≤40°COperating pressure at 07 kg/cm2.Holding volume-01 m3.
Soft Water for Utility
Make- JVS Aqua careRaw water Flow Rate- 2 m3/hrPotable water Recovery-90 %OBR-15M3
Purified Water
Make- Ahura Aqua TreatCapacity- 500 liters Flow Rate-1.7 m3/hrSupply Velocity -1.2 m/Sec.Tank Capacity- 750 lits.
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Transformer
Rating- 1600 KVAMake: Sudhir PowerType of cooling- ONANWith oil reservoir tank OLTC –On Load Tap Changer
Chiller
Make- DaikinCapacity- 192 TR @+3C.Supply to all AHU’s for maintaining the area temperature.Provision of stand by is also available
IBR Boiler
Make- ThermaxCapacity- 1.5 TPHFuel- Natural gasChimney at 30 MT exhaust.Operating pressure at 10.55 Kg/cm2.Plant supply pressure at 3.5 Kg/cm2.Pressure holding capacity at 17 kg/cm2.Feed water storage of 03 KL.
CROSS CONTAMINATION AND CONTAINMENT CAPABILITY
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Sr. No. Name of Equipment Make/Model
01 HPLC Shimadzu
02 FTIR Shimadzu
03 UV Visible Spectrophotometer Shimadzu
04 pH Meter Lab India
05 Weighing Balances Radwag
06 Autoclave (Double Door) Pharmavalid
07 Stability Chambers Mack Pharmatech
08 Incubators Mack Pharmatech
Sr. No.
01
02
03
04
05
06
07
08
09
Name of Equipment
Rotacone Vacuums Dryer
Cage Blender
27 Stn Double Rotary Compression m/c
PF 150 Capsule Filling m/c
Auto Coater
Dry Syrup Filling Machine
Blister Packing Machine (EPI2500)
Blister Packing Machine (EPI3010)
Strip Packing
Capacity/Speed
800 Liter
1600 Liter
Up to 90000 tablets /hr
Up to 1,50,000 Capsules/hr
Min-36 Kg Max-132 Kg
120 Bottles / min
40 Blisters/min
70 Blisters/min
40 Blisters/min
Model
Bectochem
Mechwell
Karnavati
Pacifab
Bectochem
Parth Engineering
Elmach
Elmach
Satellite
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Deviation Management.Change Control Management. CAPA Management.Handling of Market complaints / Recalls.Investigation and Root Cause Analysis.GMP Training.Qualifications & Validations.Approval & Control of SOP’s & other GMP documents at site.Retained sample management.Quality Risk Management.Product Quality Review.Line clearances at shop floor.In-process controls during manufacturing and packing. Sampling, Approval/Rejection of In process & Finished productsRelease of Finished Goods for distribution.Self inspection, audit & Compliance
Sampling, Testing and Release/Rejection of Raw material and Packaging material.
Analysis of In-process and Finished Products.
Reference Standards / Working standards management.
Calibration of laboratory instruments.
Stability Testing of drug products.
Environmental monitoring
Water monitoring.
Handling of OOS, OOT and incidences in laboratory.
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TABLET
Each film coated tablet contains:Amoxicillin Trihydrate USP eq. to Anhydrous Amoxicillin……………………250 mgDiluted Potassium Clavulanate USPeq. to Clavulanic Acid……………………………125 mgExcipients……………………………………………q.s.Colour: Titanium Dioxide BP
Amoxicillin and Clavulanate Potassium Tablets USP 375 mg
Each film coated tablet contains:Amoxicillin Trihydrate USPeq. to Anhydrous Amoxicillin……………………500 mgDiluted Potassium Clavulanate USPeq. to Clavulanic Acid……………………………125 mgExcipients…………………………………………….q.s.Colour: Titanium Dioxide BP
Amoxicillin and Clavulanate Potassium Tablets USP 625 mg
Each film coated tablet contains:Amoxicillin Trihydrate USPeq. to Anhydrous Amoxicillin……………………875 mgDiluted Potassium Clavulanate USP)eq. to Clavulanic Acid………………………… 125 mgExcipients……………………………………………q.s.Colour: Titanium Dioxide BP
Amoxicillin and Clavulanate Potassium Tablets USP 1000 mg
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Each uncoated dispersible tablet contains:Amoxicillin (as Trihydrate) BPeq. to Anhydrous Amoxicillin……………………125 mgExcipients…………………………………………….q.s.
Amoxicillin Trihydrate 125 mg Dispersible Tablet BP
Each uncoated dispersible tablet contains:Amoxicillin (as Trihydrate) BPeq. to Anhydrous Amoxicillin…………………250 mgExcipients……………………………………………q.s.
Amoxicillin Trihydrate 250 mg Dispersible Tablet BP
Each Hard Gelatin Capsule contains:Amoxicillin Trihydrate BPeq. to Amoxicillin……………………..250 mgExcipients……………………………………q.s.Approved colour used in Empty Hard Gelatin Capsule shell.
Amoxicillin Capsules BP 250 mg
Each Hard Gelatin Capsule contains:Amoxicillin Trihydrate BPeq. to Amoxicillin……………….……..500 mgExcipients……………………………………q.s.Approved colour used in Empty Hard Gelatin Capsule shell.
Amoxicillin Capsules BP 500 mg
CAPSULE
Amoxicillin and Clavulanate Potassium for Oral Suspension USP 312.5 mg/ 5 ml
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Each Hard Gelatin Capsule contains:Ampicillin Trihydrate BPeq. to Ampicillin……………….……..500 mgExcipients……………………………………q.s.Approved colour used in Empty Hard Gelatin Capsule shell.
Ampicillin Capsules BP 500 mg
Each Hard Gelatin Capsule contains:Ampicillin Trihydrate BPeq. to Ampicillin……………………..250 mgExcipients……………………………………q.s.Approved colour used in Empty Hard Gelatin Capsule shell.
Ampicillin Capsules BP 250 mg
Each Hard Gelatin Capsule contains:Ampicillin Trihydrate BPeq. to Ampicillin……………………..250 mgCloxacillin Sodium BPeq. to Cloxacillin……………………. 250 mgExcipients……………………………………q.s.Approved colour used in Empty Hard Gelatin Capsule shell.
Ampicillin and Cloxacillin Capsule
Each 5 ml (after reconstitution) contains:Amoxicillin Trihydrate BPeq. to Amoxicillin………………………..250 mgExcipients…………………...………………q.s.Colour: Approved colour
Amoxicillin Oral Suspension BP 250 mg /5 ml
Each 5 ml (after reconstitution) contains:Amoxicillin Trihydrate BPeq. to Amoxicillin………………………..125 mgExcipients……………………………………q.s.Colour: Approved colour
Amoxicillin Oral Suspension BP 125 mg /5 ml
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Amoxicillin and Clavulanate Potassium for Oral Suspension USP 156.25 mg/ 5 ml
Amoxicillin and Clavulanate Potassium for Oral Suspension USP 228.5 mg/ 5 ml
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DRY SYRUP LINE
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QUALITY CONTROL LAB QUALITY CONTROL LAB
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QUALITY CONTROL LAB QUALITY CONTROL LAB
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KRUX Pharma Pvt Ltd
Plot No. 10&11, Survey No. 256/P1, Nr. Balda Industrial Park, Village Balda, Valsad, Gujarat, IND - 396125
+91 99786 03556
www.kruxpharma.com [email protected]