Proventus Life Sciences Brief

Июль 21, 2022

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Proventus Life Sciences Brief

Содержание

3. OUR STORY Proventus Life Sciences was established in 1984 as CureKraft Chemicals by a group of
4. VISION & MISSION Be an integral part of pharmaceutical industry in terms of Research & Technology
5. REGULATORY COMPLIANCE Certificate of Suitability Primidone API CEP Number: RO-CEP2010-171-Rev00 WHO GMP Primidone Modafinil Tropicamide Trospium
6. WHAT WE BELIEVE IN ProVentus Life Sciences
7. FACTORY ADDRESS C–9 Industrial Complex, Maraimalai Nagar, Chennai – 603 209, Tamil Nadu, India Tel.: +91
8. SITE LAYOUT ProVentus Life Sciences
9. CORE COMPETENCIES Research & Development Kilo Lab Pilot Plant Drug Intermediate API CRAMS ProVentus Life Sciences
10. Alkylation Chloroformylation Diels – Alder reaction Epoxidation Esterification Friedel Crafts reaction Grignard reaction Polymerization Halogenation (Bromination,
11. 2,000 Sq. ft. area 8 fume hoods Process Improvement Product characterization Study of product robustness Impurity
12. FINISHED GOODS Finished goods are transferred to FG storage after completion of packing activities. Entire FG
13. Fully cGMP compliant Used for storage of Solid and Liquid Raw materials in the designated area.
14. Used for Scale up & CRAMS projects 2,000 Sq. Ft Area Clean room facility Product capacity
15. 10,000 Sq.ft area 75 People Classification 100,000 cGMP Compliant PRODUCTION FACILITY ProVentus Life Sciences
16. PRODUCTION FACILITY Meets cGMP requirements. Pharma section area is provided with controlled environment. Separate man and
17. PRODUCTION CAPACITY CLEAN ROOM - 6.5 KL INTERMEDIATE 1 - 14.5 KL INTERMEDIATE 2 - 15.75
18. UTILITIES Boiler Chiller Cooling Tower Hot Oil System Air Compressor High Vacuum Pumps Water Ejector Pumps
19. Fast-response analytical facility updated with the latest equipment. ANALYTICAL EQUIPMENT GC (with head space samplers for
20. APQR Change Control Deviation Control OOS Investigation Market complaint investigation Document controls Self inspection – Half
21. Water Foam Dry powder CO2 Wet Chemical Equipped emergency control centre Manual call points and Emergency
22. CARING FOR THE ENVIRONMENT Lean waste water recycling Safe disposal of Hazardous waste through TNPCB TNPCB
23. APIs Primidone Modafinil Biperidine Hydrochloride Trospium Chloride Tropicamide Suxomethonium Chloride DMF WHO GMP CEP WC CAS
24. APIs Propatyl Nitrate PHARMACOPOEIA CAS No. 2921-92-8 DMF TECH PACK In-house ProVentus Life Sciences Quinapyramine Sulphate
25. Intermediates N-ethyl-(3-Diphenylmethylene)-2-Methyl pyrrolidine (DPP) 4-Dimethylamino Crotonic acid Hydrochloride (DMAC) Ethyl-4-(1-hydroxy-1-methylethyl)-2-propyl-imidazole-5-carboxylate Prifinium Bromide Neratinib Olmesartan Used in
26. Intermediates L-Valine Methyl ester hydrochloride (VAM01) 2-[(2'-Cyano-biphenyl-4-ylmethyl)-amino]-3-methyl -butyric acid methyl ester Hydrochloride (VAL1) Valsartan Valsartan Used
27. Amisulpride Colistimethate Sodium Fenofibrate CAS No. 71675-87-1 ProVentus Life Sciences 8068-28-8
28. 2-Methoxy-4-amino-5-ethyl-sulfonyl benzoic acid Meta Nitro Benzaldehyde Meta Hydroxy Benzaldehye 3 - Alkyloxy Benzaldehyde 2 Alkyl 3
30. Скачать презентацию

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OUR STORY
Proventus Life Sciences was established in 1984 as CureKraft Chemicals

by a group of technocrats from ICI-UK and IIT. It was later acquired by the multifarious Chemcrown Group and it has now grown into one of India's leading API and bulk drugs manufacturers. Ethical business practices are in our ethos and has lead us to becoming a trusted partner for leading global pharmaceutical companies.

ProVentus Life Sciences

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VISION & MISSION
Be an integral part of pharmaceutical industry in terms

of Research & Technology driven by API manufacturing & development.

VISION

To provide Intermediates & APIs as per Regulatory standards, by ensuring quality parameters adhering to global standards of systems and processes with cGMP complied Infrastructure facility.
Focus on new Product Development from Lab to Commercial scale.

MISSION

ProVentus Life Sciences

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REGULATORY COMPLIANCE
Certificate of Suitability
Primidone API
CEP Number:
RO-CEP2010-171-Rev00
WHO GMP
Primidone
Modafinil
Tropicamide
Trospium Chloride
Cetrizine

Dihydrochloride
Biperidine Hydrochloride

Primidone Modafinil
Trospium Chloride
Cetrizine

EU DMF

Primidone

ProVentus Life Sciences

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WHAT WE BELIEVE IN
ProVentus Life Sciences

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FACTORY ADDRESS
C–9 Industrial Complex, Maraimalai Nagar,
Chennai – 603 209, Tamil Nadu,

India
Tel.: +91 – 44 – 47400141
Email: info@proventuslife.com

Located in Leading Industrial Belt
30 km to Chennai Airport
40 km to Chennai Port
100 m to NH45
Total Area: 5.3 Acres

ProVentus Life Sciences

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SITE LAYOUT
ProVentus Life Sciences

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CORE COMPETENCIES
Research & Development
Kilo Lab
Pilot Plant
Drug Intermediate
API
CRAMS
ProVentus Life Sciences

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Alkylation
Chloroformylation
Diels – Alder reaction
Epoxidation
Esterification
Friedel Crafts reaction
Grignard reaction
Polymerization
Halogenation (Bromination, Chlorination, Fluorination &

Iodination)
Heck & Suzuki coupling
Mannich Reaction
Nitration
Oxidation
Reduction

CAPABILITIES

We do not handle Phosgene and Hydrogen Cyanide owing to Health & Safety concerns

ProVentus Life Sciences

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2,000 Sq. ft. area
8 fume hoods
Process Improvement
Product characterization
Study of product robustness
Impurity

Synthesis
Troubleshooting for process

RESEARCH & DEVELOPMENT

STATE OF THE ART R&D FACILITY

ProVentus Life Sciences

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FINISHED GOODS
Finished goods are transferred to FG storage after completion of

packing activities.
Entire FG storage area is under controlled environment.

RAW MATERIAL

External contamination is fully controlled by:
De-dusting material before storage
Storage of material in allocated location
Sampling and dispensing in separate rooms under controlled environment.
Transporting the dispensed RM to plant in GMP manner

MATERIAL MOVEMENT

ProVentus Life Sciences

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Fully cGMP compliant
Used for storage of Solid and Liquid Raw materials

in the designated area.
Areas classified into Quarantine, Approved & Rejected.
Separate Sampling & Dispensing Booths
Solvents stored in dedicated underground storage tanks and above ground is stored in drums.

Fully controlled area with clear demarcations for Approved & Rejected.
Clear man-material movement flow.

RAW MATERIAL

Separate storage area
Areas classified into Quarantined, Approved & Rejected
Primary Packing & Secondary Packing materials are kept separately

PACKAGING
MATERIAL

FINISHED GOODS

WAREHOUSE

ProVentus Life Sciences

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Used for Scale up & CRAMS projects
2,000 Sq. Ft Area
Clean room

facility
Product capacity 1-5 Kgs

KILO LAB & PILOT PLANT

ProVentus Life Sciences

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10,000 Sq.ft area
75 People
Classification 100,000
cGMP Compliant
PRODUCTION FACILITY
ProVentus Life Sciences

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PRODUCTION FACILITY
Meets cGMP requirements.
Pharma section area is provided with controlled

environment.
Separate man and material entry for Pharma Area.
The Technical Area is under ventilated System.
Air curtains are provided at all entry points to the production area.
Adequate sanitary drains are available for waste water handling.
Water loop to provide purified water for all APIs

ProVentus Life Sciences

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PRODUCTION CAPACITY
CLEAN ROOM - 6.5 KL
INTERMEDIATE 1 - 14.5 KL
INTERMEDIATE 2

- 15.75 KL
INTERMEDIATE 3 - 10.5 KL

ProVentus Life Sciences

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UTILITIES
Boiler
Chiller
Cooling Tower
Hot Oil System
Air Compressor
High Vacuum Pumps
Water Ejector Pumps
Pure Water Plant
Softener

Plant

ProVentus Life Sciences

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Fast-response analytical facility updated with the latest equipment.
ANALYTICAL EQUIPMENT
GC (with

head space samplers for residual solvent analysis)
UV Spectrometer
HPLCs (PDA, UV and DAD detectors)
Auto-Titrator (with capability of performing Acid-base, Redox, Argentometric and KF titrations).

ProVentus Life Sciences

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APQR
Change Control
Deviation Control
OOS Investigation
Market complaint investigation
Document controls
Self inspection – Half Yearly
Vendor

Approvals

QUALITY ASSURANCE

Other Systems:
Process Validation
Equipment Qualification
Preventive Maintenance Programme
Calibration Programmes
Pest Control by External Agency
Training Programme
Medical check-up

At ProVentus, we believe in only supplying products of the highest quality. Here are some components of our extensive QA systems

ProVentus Life Sciences

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Water
Foam
Dry powder
CO2
Wet Chemical
Equipped emergency control centre
Manual call points and Emergency handsets

for alerts in the plant

Smoke detectors installed in critical areas

Trained firefighting team available around the clock

FIRE EXTINGUISHERS

EMERGENCY CONTROL SYSTEM

FIRE ALARM SYSTEM

FIRE FIGHTING TEAM

SAFETY MANAGEMENT SYSTEM

ProVentus Life Sciences

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CARING FOR THE ENVIRONMENT
Lean waste water recycling
Safe disposal of Hazardous waste

through TNPCB

TNPCB approved ETP plant for concentrated waste

ProVentus Life Sciences

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APIs
Primidone
Modafinil
Biperidine Hydrochloride
Trospium Chloride
Tropicamide
Suxomethonium Chloride
DMF
WHO GMP
CEP
WC
CAS No.
125-33-7
68693-11-8
1235-82-1
10405-02-4
1508-75-4
306-40-1
ProVentus Life Sciences

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APIs
Propatyl Nitrate
PHARMACOPOEIA
CAS No.
2921-92-8
DMF
TECH PACK
In-house
ProVentus Life Sciences
Quinapyramine Sulphate
Quinapyramine Chloride
23609-66-7
23609-65-6
BP Vet
BP Vet

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Intermediates
N-ethyl-(3-Diphenylmethylene)-2-Methyl pyrrolidine (DPP)
4-Dimethylamino Crotonic acid Hydrochloride (DMAC)
Ethyl-4-(1-hydroxy-1-methylethyl)-2-propyl-imidazole-5-carboxylate
Prifinium Bromide
Neratinib
Olmesartan
Used in
CAS No.
NCE
98548-81-3
144689-93-0
ProVentus

Life Sciences

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Intermediates
L-Valine Methyl ester hydrochloride (VAM01)
2-[(2'-Cyano-biphenyl-4-ylmethyl)-amino]-3-methyl -butyric acid methyl ester Hydrochloride

(VAL1)

Valsartan

Used in

CAS No.

6306-52-1
482577-59-3

ProVentus Life Sciences

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Amisulpride
Colistimethate Sodium
Fenofibrate
CAS No.
71675-87-1
ProVentus Life Sciences
8068-28-8

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2-Methoxy-4-amino-5-ethyl-sulfonyl benzoic acid
Meta Nitro Benzaldehyde
Meta Hydroxy Benzaldehye
3 - Alkyloxy Benzaldehyde
2

Alkyl 3 Hydroxy Benzaldehye

Used in

CAS No.
71675-87-1
99-61-6

ProVentus Life Sciences

Amisulpride

KSMs for many APIs

Treprostinil

Proventus Life Sciences Brief

Содержание

OUR STORYProventus Life Sciences was established in 1984 as CureKraft Chemicals

VISION & MISSIONBe an integral part of pharmaceutical industry in terms

REGULATORY COMPLIANCECertificate of SuitabilityPrimidone API CEP Number: RO-CEP2010-171-Rev00WHO GMPPrimidone ModafinilTropicamideTrospium ChlorideCetrizine

WHAT WE BELIEVE INProVentus Life Sciences

FACTORY ADDRESSC–9 Industrial Complex, Maraimalai Nagar,Chennai – 603 209, Tamil Nadu,

SITE LAYOUTProVentus Life Sciences

CORE COMPETENCIESResearch & DevelopmentKilo LabPilot PlantDrug IntermediateAPICRAMSProVentus Life Sciences

AlkylationChloroformylationDiels – Alder reactionEpoxidationEsterificationFriedel Crafts reactionGrignard reactionPolymerizationHalogenation (Bromination, Chlorination, Fluorination &

2,000 Sq. ft. area8 fume hoodsProcess ImprovementProduct characterizationStudy of product robustnessImpurity

FINISHED GOODSFinished goods are transferred to FG storage after completion of

Fully cGMP compliantUsed for storage of Solid and Liquid Raw materials

Used for Scale up & CRAMS projects2,000 Sq. Ft AreaClean room

10,000 Sq.ft area75 PeopleClassification 100,000cGMP CompliantPRODUCTION FACILITYProVentus Life Sciences

PRODUCTION FACILITYMeets cGMP requirements. Pharma section area is provided with controlled

PRODUCTION CAPACITYCLEAN ROOM - 6.5 KLINTERMEDIATE 1 - 14.5 KLINTERMEDIATE 2

UTILITIESBoilerChillerCooling TowerHot Oil SystemAir CompressorHigh Vacuum PumpsWater Ejector PumpsPure Water PlantSoftener

Fast-response analytical facility updated with the latest equipment. ANALYTICAL EQUIPMENTGC (with

APQRChange ControlDeviation ControlOOS InvestigationMarket complaint investigationDocument controlsSelf inspection – Half YearlyVendor

WaterFoamDry powderCO2Wet ChemicalEquipped emergency control centreManual call points and Emergency handsets

CARING FOR THE ENVIRONMENTLean waste water recyclingSafe disposal of Hazardous waste

APIsPrimidoneModafinilBiperidine HydrochlorideTrospium ChlorideTropicamideSuxomethonium ChlorideDMFWHO GMPCEPWCCAS No.125-33-768693-11-81235-82-110405-02-41508-75-4306-40-1ProVentus Life Sciences

APIsPropatyl NitratePHARMACOPOEIACAS No.2921-92-8DMFTECH PACKIn-houseProVentus Life SciencesQuinapyramine SulphateQuinapyramine Chloride23609-66-723609-65-6BP VetBP Vet

IntermediatesN-ethyl-(3-Diphenylmethylene)-2-Methyl pyrrolidine (DPP)4-Dimethylamino Crotonic acid Hydrochloride (DMAC)Ethyl-4-(1-hydroxy-1-methylethyl)-2-propyl-imidazole-5-carboxylatePrifinium BromideNeratinibOlmesartanUsed inCAS No. NCE98548-81-3144689-93-0ProVentus

IntermediatesL-Valine Methyl ester hydrochloride (VAM01) 2-[(2'-Cyano-biphenyl-4-ylmethyl)-amino]-3-methyl -butyric acid methyl ester Hydrochloride

AmisulprideColistimethate SodiumFenofibrateCAS No. 71675-87-1ProVentus Life Sciences8068-28-8

2-Methoxy-4-amino-5-ethyl-sulfonyl benzoic acidMeta Nitro BenzaldehydeMeta Hydroxy Benzaldehye 3 - Alkyloxy Benzaldehyde 2

Похожие презентации

OUR STORY
Proventus Life Sciences was established in 1984 as CureKraft Chemicals

VISION & MISSION
Be an integral part of pharmaceutical industry in terms

REGULATORY COMPLIANCE
Certificate of Suitability
Primidone API
CEP Number:
RO-CEP2010-171-Rev00
WHO GMP
Primidone
Modafinil
Tropicamide
Trospium Chloride
Cetrizine

WHAT WE BELIEVE IN
ProVentus Life Sciences

FACTORY ADDRESS
C–9 Industrial Complex, Maraimalai Nagar,
Chennai – 603 209, Tamil Nadu,

SITE LAYOUT
ProVentus Life Sciences

CORE COMPETENCIES
Research & Development
Kilo Lab
Pilot Plant
Drug Intermediate
API
CRAMS
ProVentus Life Sciences

Alkylation
Chloroformylation
Diels – Alder reaction
Epoxidation
Esterification
Friedel Crafts reaction
Grignard reaction
Polymerization
Halogenation (Bromination, Chlorination, Fluorination &

2,000 Sq. ft. area
8 fume hoods
Process Improvement
Product characterization
Study of product robustness
Impurity

FINISHED GOODS
Finished goods are transferred to FG storage after completion of

Fully cGMP compliant
Used for storage of Solid and Liquid Raw materials

Used for Scale up & CRAMS projects
2,000 Sq. Ft Area
Clean room

10,000 Sq.ft area
75 People
Classification 100,000
cGMP Compliant
PRODUCTION FACILITY
ProVentus Life Sciences

PRODUCTION FACILITY
Meets cGMP requirements.
Pharma section area is provided with controlled

PRODUCTION CAPACITY
CLEAN ROOM - 6.5 KL
INTERMEDIATE 1 - 14.5 KL
INTERMEDIATE 2

UTILITIES
Boiler
Chiller
Cooling Tower
Hot Oil System
Air Compressor
High Vacuum Pumps
Water Ejector Pumps
Pure Water Plant
Softener

Fast-response analytical facility updated with the latest equipment.
ANALYTICAL EQUIPMENT
GC (with

APQR
Change Control
Deviation Control
OOS Investigation
Market complaint investigation
Document controls
Self inspection – Half Yearly
Vendor

Water
Foam
Dry powder
CO2
Wet Chemical
Equipped emergency control centre
Manual call points and Emergency handsets

CARING FOR THE ENVIRONMENT
Lean waste water recycling
Safe disposal of Hazardous waste

APIs
Primidone
Modafinil
Biperidine Hydrochloride
Trospium Chloride
Tropicamide
Suxomethonium Chloride
DMF
WHO GMP
CEP
WC
CAS No.
125-33-7
68693-11-8
1235-82-1
10405-02-4
1508-75-4
306-40-1
ProVentus Life Sciences

APIs
Propatyl Nitrate
PHARMACOPOEIA
CAS No.
2921-92-8
DMF
TECH PACK
In-house
ProVentus Life Sciences
Quinapyramine Sulphate
Quinapyramine Chloride
23609-66-7
23609-65-6
BP Vet
BP Vet

Intermediates
N-ethyl-(3-Diphenylmethylene)-2-Methyl pyrrolidine (DPP)
4-Dimethylamino Crotonic acid Hydrochloride (DMAC)
Ethyl-4-(1-hydroxy-1-methylethyl)-2-propyl-imidazole-5-carboxylate
Prifinium Bromide
Neratinib
Olmesartan
Used in
CAS No.
NCE
98548-81-3
144689-93-0
ProVentus

Intermediates
L-Valine Methyl ester hydrochloride (VAM01)
2-[(2'-Cyano-biphenyl-4-ylmethyl)-amino]-3-methyl -butyric acid methyl ester Hydrochloride

Amisulpride
Colistimethate Sodium
Fenofibrate
CAS No.
71675-87-1
ProVentus Life Sciences
8068-28-8

2-Methoxy-4-amino-5-ethyl-sulfonyl benzoic acid
Meta Nitro Benzaldehyde
Meta Hydroxy Benzaldehye
3 - Alkyloxy Benzaldehyde
2