posh chemicals p. ltd - formulation intermediates, … chemicals registered office:!! posh...
TRANSCRIPT
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Posh Chemicals
Registered Office:!!Posh Chemicals Private Limited!202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad - 500 016. INDIA.!Phones : + 91 40 2341 8086, + 91 40 2341 7926 Fax : +91 40 2341 8087.!Email : [email protected]!www.poshchem.com!
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§ Founded in 1994!!§ Strategically located in Hyderabad, Andhra Pradesh, India, the
pharma hub of the world!
§ Key Activities are Manufacturing of API’s, Formulation Intermediates, Intermediates, Fine Chemicals, Custom Synthesis, and Contract Manufacturing!
§ Exports to more than 30 countries!
About Posh Chemicals
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Key Focus Areas!cGXP Compliance
Quality Products
On time Delivery
Customer Satisfaction
Environment Friendly
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Manufacturing Infrastructure
8000 sq. mts. Plant area
100 KL reactor
capacity Granulation
Micronization Fluid bed Drying ANFD
Filter Press Compacting RO & Ultra filtration
Classified Clean rooms
Multiple Effect
Evaporator
4!
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Manufacturing : Unit -I
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Manufacturing : Unit -II
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Manpower Administration, 15,
13%
Production, 34, 29%
Maintenance, 18, 16%
Quality Control, 26, 23%
Quality Assurance, 11, 10%
Ware House, 6, 5% R&D , 5, 4%
7!
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Revenue
8!
0
50
100
150
200
250
300
350
400
2008 2009 2010 2011 2012
2013 2014
In Million Rs.
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Regulatory Inspections
2002 – US FDA
2009 - COFEPRIS
2013 - US FDA
2014 – EDQM , COFEPRIS
2015 - USFDA
9!
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Quality!!
§ Quality control plays a major role in the POSH day to day activities!
§ Posh is equipped with a dedicated Quality Control and Quality Assurance Teams!
§ Our quality control equipment comply with 21 CFR Part 11 guidelines!
§ In-house testing facilities are available for all kinds of analysis - Raw Materials, In-Process and Finished Products!
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Quality Control Labs!UPLC
Gas Chromatography
HPLC
HPTLC
UV Spectrometer
FTIR
TOC
Stability Chambers
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Research & Development • Dedicated R&D lab for new products
• Process development and lab to Plant level scale up • In-house impurity synthesis capability
• Process optimization
13!
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Regulatory Affairs • Dedicated regulatory function
• New DMF filings and updates
• DMFs filed with: • US FDA • EDQM • Spanish Medicines Agency • Taiwan FDA • MFDS (South Korea)
14!
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Compliance
US FDA
EU GMP
WHO GMP
COFEPRIS ISO 9001 :
2008 ISO 14001 :
2004
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API’s!
Phenazopyridine HCl USP
Phenazopyridine DC Granules Customized
Sulfasalazine USP/Ph.Eur/BP
Sulfapyridine USP
Valacyclovir USP/Ph. Eur
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API’s!
Sulfamethizole Ph.Eur/BP
Ferrous Calcium Citrate In house
Tretinoin USP / BP
N N Dihydroxymethyl Carbamide Customized
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Intermediates!Thiosemicarbazide - CAS# 79-19-6
2,6 Diaminopyridine - CAS# 141-86-6
2- Amino-5-methyl-1,3,4- thiadiazole - CAS# 108-33-8
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Under Development
Clopidogrel Bisulfate
Citalopram Hydrobromide
Celecoxib
19!
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Capacity Addition • New state of the art upcoming facilities meeting all GMP
norms planned in suburbs of Hyderabad (Unit III) and Vizag (Unit IV)
• Regulatory approvals and construction in progress for Vizag Unit
• Production capacities of 1575 TPA (Unit III) and 500 TPA
(Unit IV)
• Proposed investments to the tune of INR 1 Billion
• Targeting completion of Phase-I by end of 2016
20!
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21!
Beyond Now...!
19!
Capacity Addition : Unit III & Unit VI
Expanding to New Markets
Increasing product portfolio
Global tie ups for ANDAs
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Thank You !!Please visit www.poshchem.com to know more about us!!