Praveen Labs (P) Ltd Company Profile

Praveen Laboratories (P) Limited

21/04/23 company profile 1

Praveen Laboratories (P) LimitedAbout 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.


Praveen Laboratories (P) LimitedGeneral Information

Factory Address: Praveen Laboratories (p) Ltd.,

Plot No.-1, Block No. 206,

At Post Jolwa, Ta.Palsana,

Dist.Surat-Gujarat-IndiaPhone: +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



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.




List of Products1. Cetirizine Hydrochloride

2. Clopidogrel Bisulfate

3. Levocetirizine Hydrochloride

4. Lamotrigine

5.S-Amlodipine Besylate

Praveen Laboratories (P) LimitedJourney 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

.


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.

Praveen Laboratories (P) LimitedFacility 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.

21/04/23 8

Sr. No Department Area

1 Manufacturing Area 4600 Sq. Ft.

2 Pharma Processing Area (Pharma Block-II and IV) 8470 Sq. Ft.

3 Quality Assurance 2880 Sq. Ft

4 Quality Control 1650 Sq. Ft.

5 R & D 630 Sq. Ft.

6 Warehouse 2950 Sq. Ft.

7 Utilities & Engineering 2100 Sq. Ft.

8 Administration office 1100 Sq. Ft.


Name Designation Qualification Experience

Mr. Mahesh Vakharia Managing Director B.Sc. 20 Years

Mr. Hetul Mehta Technical Director B. Tech (Chemical) 16 Years

Mr. Kamal Bhowmik General Manager M.Sc. 23 Years

Mr. Bimal Pandya Sr.Manager-QA M.Sc. 20 Years

Dr. Vipul R. Patel Sr. Manager-Production Ph.D. 17 Years

Mr. B. M.Choudhari Manager-QC M.Sc. 21 Years

Mr. Nilesh Devdhara Manager-HR B. Com., L.L.B. 16 Years


List of Key Personnel


Site layout


Ground Floor lay Out


First Floor lay Out


Man & Material Movement


Warehouse (Solid Material)


Air Handling Unit

Air Handling unit is in compliance of class 100000 area.



Ground Floor AHU System


Proposed Facility Ground Floor AHU System


Proposed Facility First Floor AHU System


Major Process equipments

SS Reactors 9 Nos.

GL Reactors 5 Nos.

SS Centrifuge of 48” & 36” 4 Nos.

Rubber lined centrifuges of 48” 2 Nos.

Fluid Bed Dryer 2 No.

Tray dryers 2 Nos.

Blender 1 No.

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


Praveen Laboratories (P) LimitedQuality Control Instruments

GC 1 Nos.

HPLC 2 Nos.

Stability Chambers 3 Nos.

Analytical Balance 2 Nos.

KF Apparatus 1 No.

Vacuum Oven / Hot Air Oven 1 No.

UV Spectrophotometer 1 No.

Auto Titrator 1 No.

Polarimeter 1 No.

Melting Point Apparatus 2 No.

Shieve Shaker 1 No.

pH meter 1 No.



Major Utilities

DG Set 75 KVA.

DM Plant 500 ltr/hr

Softener Plant 500 ltr /hr

Hot Water Plant 1100 liter

Cooling Tower 3000 liter

Chilling Plant 25-30 TR

Air Compressor 1 No. of 0-10 kg pressure

Air Handling Unit 1500, 3000 , 4200 & 5200 CFM

Boiler (Thermic fluid) 1 No.

Steam Boiler 600 Kg / hr



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.


Schematic diagram of Water System


Schematic diagram of New Water System


Praveen Laboratories (P) LimitedQuality 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 Batch release for commercial distribution is done by QA.

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.



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.




Documents

Praveen Labs (P) Ltd Company Profile