striving to excellence in api manufacturing sound r & d...

Striving to excellence in API manufacturing

Sound R & D for product development and CramsStriving towards excellence in API manufacturing

The Mission The Mission

• Be a facility capable of providing highest standards of API forregulated and developing markets

•Focus on product development from lab to kilo lab. Scale up throughpilot plant to commercial production batch and to be a responsibleCRAMs partner

•Provide Quick and Appropriate response to the needs of all stake-holders

•Be a Preferred and Reliable Partner through commitment to Intellectual Property and Integrity

•To excel as research based , technology driven API manufacturingand development organisation

Vision

Mission

History & Milestones

1984: Incorporated for the manufacture of Pharmaceuticals asCurekraft Chemicals

1991: Acquired by the Chemcrown group

2005:

• Change in management control

• Renamed as ProVentus Life Sciences 2006: • Manufacture of generic APIs for human consumption

• Commencement of CRAMS activities 2007: Inauguration of R&D and cGMP Kilo-lab

2008: Inauguration of new cGMP manufacturing facilities

Revamp and relocation of intermediates manufacturing facility tomake the facility fully cGMP compliant

2009:

Location

Maraimalai Nagar, Chennai, Tamil Nadu

- In a leading industrial belt

- 30 Km from Chennai airport

- 40 Km from Chennai sea port

- Just off an arterial highway - NH45

- Land area: 5.3 Acres (3 acres is unutilized)

Site Plan

UTILITIES VACANT EMPTY BLDG.

WARE HOUSE

B L

SOLVENT O

STORAGE C VACANT VACANT VACANT

K 1

ENTRY

V A C R&D, KILO-LAB

EMPTY BLDG. ANALYTICAL A N T

ENTRY

Process Research

Scale up : Kilo Lab & Pilot Plant

Generic API Manufacture

Emerging Technologies

High Potency Compunds-

Research & Scale up

Large scale manufacture of Generic APIs, NCEs &

Intermediates

FutureFuture

Activities

Span of Activities

To be provide integrated drug discovery programs of high quality

API Pre- Pilot Drug Med Scale Animal Clinic Manufac-Biology Design formulation Manufac-Chem up Tox Trial turing development turing

Long-term strategy; partnership based

Current

Not planned as a core-competency; to offer through partners

Core Competencies

Process research:

• Produce high quality of API in cGMP compliance plant

• Scale-up process developed by customer;

• Develop process and scale-up to provide multi-kilo material

• Route selection

• Process optimization - Reaction conditions, Solvent optimization, cycle-

time optimization

Contract manufacturing

Custom synthesis

APIs in manufacturing

Primidone

Oxybutynin hydrochloride

Isopropamide Iodine

Tropicamide

Trospium chloride

Raloxifene hydrochloride

Modafinil

Propatyl Nitrate

Gabapentin

APIs under development

Olmesartan

Brinzolamide

Chlorthalidone

APIs ready for production

Calcium Dobesilate

Biperiden hydrochloride

Ambroxol

Veterinary APIs in manufacturing

Febantel

Oxyclozanide

Quinapyramine salts

INFRASTRUCTURE

&

CAPABILITIES

Manufacturing - Bay 1

Temperature Capacity MOC Pressure

Range

1. 3,000 L Stainless Steel FV to 4 atm -5 - 135 C



4. 2,000 L Glassed steel FV to 4 atm -5 - 135 C

5. 2,000 L Glassed steel FV to 4 atm -5 - 135 C

6. 2,500 L PP FRP --- ---

1. Centrifuge SS 316 48”


3. Tray Dryer SS 316 48 Tray

Manufacturing - Bay 2

Capacity MOC Pressure Temperature

1. 500 L Glassed steel FV to 6 atm -15 to + 135 C C , 2. 1000 L Glassed steel FV to 6 atm -15 to + 135 C

3. 3000 L Glassed steel FV to 6 atm -15 to + 210 C

4. 2000 L Stainless Steel FV to 6 atm -15 to + 135 C



3. Vacuum Tray Dryer SS 316 24 Tray

4. Multi-mill SS 316 100 Kg / hr

5. Sieve-shaker SS 316 22” dia

6. Octagonal blender SS 316 500 L

7. Rotary vacuum dryer (to be installed) SS 316 1,000 L

Kilo Lab

Capacity MOC Temperature

1. 100 L Suite 1 All glass Atm to FV -78 to +250 C

2. 100 L Suite 1 All glass Atm to FV -78 to +250 C

3. 100 L Suite 2 All glass Atm to FV -78 to +250 C Class 100,000

1. Nutsche filter SS 316 25 L

2. Nutsche filter PP FRP 50 L



5. Multi-mill SS 316 10 Kg / hr

6. Sieve-shaker SS 316 12” dia

Utilities

• Steam - 600 Kg / hr

• Chilled Brine - 30 TR @ 0 deg. C

• Cooling water - 100 TR

• Hot Oil - 200,000 Kcal/hr @ 250 deg. C

• High vacuum - 1 mm Hg

• House vacuum @ 720 mm Hg

• Nitrogen - Cylinder bank

Analytical

HPLC

Shimadzu Prominence PDA, ELS detectors

Shimadzu Prominence UV, ELS detectors, Auto sampler

GC

Perkin Elmer Head Space Sampler

UV

Shimadzu

Auto Titrator

Metrohm 794 Titration capabilities - Non-aqueous, acid-base, redox, argentometric & KF

The following analysis are currently outsourced:

1H & 13-C-NMR, Elemental analysis, Mass spectra (LC-MS / GC-MS / EI / CI), Particle Size Analysis (Laser based with long bench), X-Ray diffraction (single / powder), Infrared

Regulatory Status

• Kilo-lab & Manufacturing facilities conform to cGMP requirement

• US-FDA inspection expected in 2011

• Regulatory support can be provided with all products

Audited by our customers which include Big Pharmaceutical

companies from USA and Europe

Looking ahead ..

Pilot Plant (4Q 2010)

High-end Fluorination capabilities (2Q 2011) • At laboratory and kilo scale

Containment facility(1Q 2012) • Research, Scale-up & Manufacture of high potency compounds

Large scale Manufacturing of APIs and Intermediates (3Q 2011) • Manufacture of NCEs

Why ProVentus ?

1. Strategic location - Chennai, South India; a prime location Insulated from major pharmaceutical companies Availability of talent-pool

2. Established track record with leading pharma-majors across the globe

3. Management & operations expertise available

4. Proposed growth plans encompasses the entire spectrum of chemistry related pharmaceutical services

Contact Information

ProVentus Life Sciences Private Limited

C-9, Industrial Estate

Maraimalainagar

Chennai - 603209

Tamil Nadu

India

Tel:+91-44-47400141

E-Mail: [email protected]

Web: www.proventuslife.com

THANK YOU

WE LOOK FORWARD TO

ASSOCIATING WITH YOU

striving to excellence in api manufacturing sound r & d...

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