Praveen Labs (P) LTD Company Profile

Praveen Laboratories (P) Limited
22-09-2013
company profile

About us Praveen Labs Private Limited was founded by Mr. Mahesh Vakharia & Mr. Hetul
Mehta in 1996 for the manufacturing of Bulk Active Pharmaceuticals and Key
Intermediates for APIs. Mr. Mahesh Vakharia, is the Managing Director of the company and Mr .Hetul Mehta is Technical Director of the company. The company is located at about 22 KM from Surat city towards Surat Bardoli road. Surat is very well connected with the metro cities like Mumbai, Delhi and Ahmedabad by Rail, Road & Airways. The Factory is located 50 KMs from the Surat air port.
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company profile

General Information Factory Address: Praveen Laboratories (p) Ltd.,
Plot No.-1, Block No. 206, At Post Jolwa, Ta.Palsana, Dist.Surat-Gujarat-India Phone: +91-02622-273134,276143
Registered office: Praveen Laboratories (p) Ltd.,

720, 7th Floor , Golden Point, Falsa Wadi, Ring road , Surat 395003 Gujarat- India Phone :+91 261-2322816/6622816 Fax : +91 261 6641275 Mail : [email protected]; [email protected] Website : www. praveenlabs.com
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company profile

Exports
Praveen Labs is an API/Key Intermediate Production-
oriented company. Praveen lab is registered with the

manufacturing license No. G/1365. Majority of production is catered to Export market, About 70% is shipped to Israel., Bangladesh, Egypt, Iran, Latin America, Mexico, Vietnam, South Korea, China, Singapore and CIS
countries etc.
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List of Products
1. Cetirizine Hydrochloride
2. Clopidogrel Bisulfate 3. Levocetirizine Hydrochloride 4. Lamotrigine 5.S-Amlodipine Besylate
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company profile

Journey for accreditations
2005 :GMP certificate, Issued by State FDA
2005 :Patent filed in IPO for Levo cetirizine

2007 :Cetirizine & Lamotrigine DMFs submission as per customer need. 2008 :Patent filed in PCT for Clopidogrel Form-1
2011 :License renewed up to 2016 by State FDA and GMP certification.

2008 :A state of art facility construction was started and completed, qualification is under progres. This facility is aimed mainly to produce and cater the APIs to global markets.
2013 : WHO-GMP certification and Written Confirmation certification for EU export
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company profile
QUALITY POLICY
To achieve and develop quality awareness among the employees for manufacturing active pharmaceutical ingredients and its intermediates in national and international market
Top management is committed to improve the effectiveness of the Quality Management System on a continual basis through training, measurement and development by all within the organization.
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company profile

Facility Overview

The total area is of 70,000 Sq.Ft Construction is about 25,000 Sq. Ft Production area is divided into 3 blocks in old facility & 1 block in new facility. All 3 blocks contains process equipments for penultimate stage processing. Final Pharma area and packaging areas are separated with filtered AIR supply. Area Occupancy of the each Dept.
Sr. No 1 2 3 4 5 6 7 Manufacturing Area Pharma Processing Area (Pharma Block-II and IV) Quality Assurance Quality Control R&D Warehouse Utilities & Engineering Department Area 4600 Sq. Ft. 8470 Sq. Ft. 2880 Sq. Ft 1650 Sq. Ft. 630 Sq. Ft. 2950 Sq. Ft. 2100 Sq. Ft.
Administration office
1100 Sq. Ft.
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List of Key Personnel
Name Mr. Mahesh Vakharia Mr. Hetul Mehta Mr. Kamal Bhowmik Mr. Bimal Pandya Dr. Vipul R. Patel Mr. B. M.Choudhari Mr. Nilesh Devdhara 22-09-2013 Designation Managing Director Technical Director General Manager Sr.Manager-QA Sr. Manager-Production Manager-QC Manager-HR B.Sc. B. Tech (Chemical) M.Sc. M.Sc. Ph.D. M.Sc. B. Com., L.L.B. company profile Qualification Experience 20 Years 16 Years 23 Years 20 Years 17 Years 21 Years 16 Years 9
Site layout
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Ground Floor lay Out
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First Floor lay Out
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Man & Material Movement
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Warehouse (Solid Material)
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Air Handling Unit Air Handling unit is in compliance of class 100000 area.
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Ground Floor AHU System
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Proposed Facility Ground Floor AHU System
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Proposed Facility First Floor AHU System
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Major Process equipments
SS Reactors GL Reactors SS Centrifuge of 48 & 36 Rubber lined centrifuges of 48 Fluid Bed Dryer
9 Nos. 5 Nos. 4 Nos. 2 Nos. 2 No.
Tray dryers
Blender
2 Nos.
1 No.
Total capacities of Reactors in all the Block is about 50 KL
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Quality Control Instruments

GC
1 Nos.
HPLC
Stability Chambers Analytical Balance KF Apparatus
2 Nos.
3 Nos. 2 Nos. 1 No.
Vacuum Oven /
Hot Air Oven
1 No.
1 No. 1 No. 1 No.
UV Spectrophotometer
Auto Titrator Polarimeter
Melting Point Apparatus

Shieve Shaker pH meter
2 No.
1 No. 1 No.
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20

Major Utilities
DG Set DM Plant Softener Plant Hot Water Plant Cooling Tower Chilling Plant Air Compressor Air Handling Unit Boiler (Thermic fluid)
75 KVA. 500 ltr/hr 500 ltr /hr 1100 liter 3000 liter 25-30 TR 1 No. of 0-10 kg pressure 1500, 3000 , 4200 & 5200 CFM 1 No.
Steam Boiler
600 Kg / hr
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22-09-2013

Water system Raw water is sourced from the ground. The Raw water is treated in softeners. Soft water is pumped to sand
filter, carbon filter and R.O, then passed to ion exchange

resins (anion + cation Mixed bed) to produce D.M water. D.M.Water is stored and distributed through UV in closed loop.
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Schematic diagram of Water System
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Schematic diagram of New Water System
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Quality Unit & Systems QA & QC Departments are independent and monitors the Quality System. Responsibilities and authorities of all the personnel working in Quality team are prescribed and followed.
Major responsibilities like distribution is done by QA.
Batch release for commercial
22-09-2013
QA is involved in Issuance of BPR, ECR, Logs, Formats, STPs, SOPs etc. Document control, Change control, Deviation control, Rejects, Recalls, complaint handling, Product quality review training and internal audits etc.
company profile
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Research & Development Praveen labs is facilitated with R&D division for

Process development and optimization. Yield improvements and process improvements. Establishment of Specifications Development and synthesis of impurity Change controls/deviations pertinent to the process review. Investigation for process need and to establish corrective actions for process parameters.
company profile 26
22-09-2013
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Praveen Laboratories (P) Limited

Praveen Laboratories (P) Limited

Praveen Laboratories (P) Limited

Registered office: Praveen Laboratories (p) Ltd.,

Praveen Laboratories (P) Limited

oriented company. Praveen lab is registered with the

Praveen Laboratories (P) Limited

Praveen Laboratories (P) Limited

2005 :GMP certificate, Issued by State FDA

2005 :Patent filed in IPO for Levo cetirizine

2011 :License renewed up to 2016 by State FDA and GMP certification.

2013 : WHO-GMP certification and Written Confirmation certification for EU export

Praveen Laboratories (P) Limited

1100 Sq. Ft.

Praveen Laboratories (P) Limited

Ground Floor lay Out

First Floor lay Out

Man & Material Movement

Warehouse (Solid Material)

Praveen Laboratories (P) Limited

Ground Floor AHU System

Proposed Facility Ground Floor AHU System

Proposed Facility First Floor AHU System

Praveen Laboratories (P) Limited

9 Nos. 5 Nos. 4 Nos. 2 Nos. 2 No.

Total capacities of Reactors in all the Block is about 50 KL

Praveen Laboratories (P) Limited

Hot Air Oven

Auto Titrator Polarimeter

Melting Point Apparatus

Praveen Laboratories (P) Limited

Praveen Laboratories (P) Limited

filter, carbon filter and R.O, then passed to ion exchange

Schematic diagram of Water System

Schematic diagram of New Water System

Praveen Laboratories (P) Limited

Major responsibilities like distribution is done by QA.

Batch release for commercial

Praveen Laboratories (P) Limited

Praveen Laboratories (P) Limited

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