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Praveen Laboratories (P) Limited

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company profile

Praveen Laboratories (P) Limited


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

Praveen Laboratories (P) Limited


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 : Info@praveenlabs.com; admin@praveenlabs.com Website : www. praveenlabs.com

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company profile

Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


List of Products
1. Cetirizine Hydrochloride
2. Clopidogrel Bisulfate 3. Levocetirizine Hydrochloride 4. Lamotrigine 5.S-Amlodipine Besylate

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company profile

Praveen Laboratories (P) Limited


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.

22-09-2013

company profile

Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited


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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Praveen Laboratories (P) Limited

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

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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.
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Praveen Laboratories (P) Limited


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.
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