Praveen Labs (p) Ltd Company Profile 4j2v3g
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Praveen Laboratories (P) Limited
22-09-2013
company profile
1
Praveen Laboratories (P) Limited 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.
22-09-2013
company profile
2
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
ed 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] Website : www. praveenlabs.com
22-09-2013
company profile
3
Praveen Laboratories (P) Limited Exports Praveen Labs is an API/Key Intermediate Production-
oriented company. Praveen lab is ed 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. 22-09-2013
company profile
4
Praveen Laboratories (P) Limited List of Products 1. Cetirizine Hydrochloride 2. Clopidogrel Bisulfate 3. Levocetirizine Hydrochloride 4. Lamotrigine 5.S-Amlodipine Besylate
22-09-2013
company profile
5
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
.
22-09-2013
company profile
6
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
7
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
22-09-2013
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
istration office
1100 Sq. Ft.
8
Praveen Laboratories (P) Limited List of Key Personnel 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
22-09-2013
company profile
9
Site layout
22-09-2013
company profile
10
Ground Floor lay Out
22-09-2013
company profile
11
First Floor lay Out
22-09-2013
company profile
12
Man & Material Movement
22-09-2013
company profile
13
Warehouse (Solid Material)
22-09-2013
company profile
14
Praveen Laboratories (P) Limited Air Handling Unit Air Handling unit is in compliance of class 100000 area.
22-09-2013
company profile
15
Ground Floor AHU System
22-09-2013
company profile
16
Proposed Facility Ground Floor AHU System
22-09-2013
company profile
17
Proposed Facility First Floor AHU System
22-09-2013
company profile
18
Praveen Laboratories (P) Limited 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
22-09-2013
company profile
19
Praveen Laboratories (P) Limited Quality 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.
22-09-2013
company profile
20
Praveen Laboratories (P) Limited 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
22-09-2013
company profile
21
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 ed 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. 22-09-2013
company profile
22
Schematic diagram of Water System
22-09-2013
company profile
23
Schematic diagram of New Water System
22-09-2013
company profile
24
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.
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.
22-09-2013
Batch release for commercial
company profile
25
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.
22-09-2013
company profile
26
Praveen Laboratories (P) Limited
22-09-2013
company profile
27
22-09-2013
company profile
1
Praveen Laboratories (P) Limited 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.
22-09-2013
company profile
2
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
ed 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] Website : www. praveenlabs.com
22-09-2013
company profile
3
Praveen Laboratories (P) Limited Exports Praveen Labs is an API/Key Intermediate Production-
oriented company. Praveen lab is ed 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. 22-09-2013
company profile
4
Praveen Laboratories (P) Limited List of Products 1. Cetirizine Hydrochloride 2. Clopidogrel Bisulfate 3. Levocetirizine Hydrochloride 4. Lamotrigine 5.S-Amlodipine Besylate
22-09-2013
company profile
5
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
.
22-09-2013
company profile
6
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
7
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
22-09-2013
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
istration office
1100 Sq. Ft.
8
Praveen Laboratories (P) Limited List of Key Personnel 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
22-09-2013
company profile
9
Site layout
22-09-2013
company profile
10
Ground Floor lay Out
22-09-2013
company profile
11
First Floor lay Out
22-09-2013
company profile
12
Man & Material Movement
22-09-2013
company profile
13
Warehouse (Solid Material)
22-09-2013
company profile
14
Praveen Laboratories (P) Limited Air Handling Unit Air Handling unit is in compliance of class 100000 area.
22-09-2013
company profile
15
Ground Floor AHU System
22-09-2013
company profile
16
Proposed Facility Ground Floor AHU System
22-09-2013
company profile
17
Proposed Facility First Floor AHU System
22-09-2013
company profile
18
Praveen Laboratories (P) Limited 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
22-09-2013
company profile
19
Praveen Laboratories (P) Limited Quality 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.
22-09-2013
company profile
20
Praveen Laboratories (P) Limited 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
22-09-2013
company profile
21
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 ed 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. 22-09-2013
company profile
22
Schematic diagram of Water System
22-09-2013
company profile
23
Schematic diagram of New Water System
22-09-2013
company profile
24
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.
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.
22-09-2013
Batch release for commercial
company profile
25
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.
22-09-2013
company profile
26
Praveen Laboratories (P) Limited
22-09-2013
company profile
27
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