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Posh Chemicals Registered Office: Posh Chemicals Private Limited 202, S.V'S Classic Residency, 63853/2, 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

Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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Page 1: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 2: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

§  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

Page 3: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Key Focus Areas!cGXP Compliance

Quality Products

On time Delivery

Customer Satisfaction

Environment Friendly

Page 4: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 5: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Manufacturing : Unit -I

Page 6: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Manufacturing : Unit -II

Page 7: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 8: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Revenue

8!

0

50

100

150

200

250

300

350

400

2008 2009 2010 2011 2012

2013 2014

In Million Rs.

Page 9: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Regulatory Inspections

2002 – US FDA

2009 - COFEPRIS

2013 - US FDA

2014 – EDQM , COFEPRIS

2015 - USFDA

9!

Page 10: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad
Page 11: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 12: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Quality Control Labs!UPLC

Gas Chromatography

HPLC

HPTLC

UV Spectrometer

FTIR

TOC

Stability Chambers

Page 13: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 14: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 15: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Compliance

US FDA

EU GMP

WHO GMP

COFEPRIS ISO 9001 :

2008 ISO 14001 :

2004

Page 16: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

API’s!

Phenazopyridine HCl USP

Phenazopyridine DC Granules Customized

Sulfasalazine USP/Ph.Eur/BP

Sulfapyridine USP

Valacyclovir USP/Ph. Eur

Page 17: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

API’s!

Sulfamethizole Ph.Eur/BP

Ferrous Calcium Citrate In house

Tretinoin USP / BP

N N Dihydroxymethyl Carbamide Customized

Page 18: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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

Page 19: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Under Development

Clopidogrel Bisulfate

Citalopram Hydrobromide

Celecoxib

19!

Page 20: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

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!

Page 21: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

21!

Beyond Now...!

19!

Capacity Addition : Unit III & Unit VI

Expanding to New Markets

Increasing product portfolio

Global tie ups for ANDAs

Page 22: Posh Chemicals P. Ltd - Formulation Intermediates, … Chemicals Registered Office:!! Posh Chemicals Private Limited! 202, S.V'S Classic Residency, 6‐3‐853/2, Ameerpet, Hyderabad

Thank You !!Please visit www.poshchem.com to know more about us!!