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LAXMI GENCHEM SCIENCES
SOLUTIONS FOR HEALTHIER LIFE
1
About us
 Laxmi Genchem Sciences Pvt Ltd is a contract research & generic API manufacturing
organization which services global Pharma industry established in 2013; operated in
Hyderabad, INDIA.
Vision:
 Our mission is to focus on business to rapidly assist our partners in development of NCEs
& Generic API non-infringing route scouting in a cost effective manner as per global
regulatory requirements.
 Our team committed to absolute assurance of best quality of Ingredients with a strong
regulatory backup.
Mission:
 Quality requirements as per ICH guidelines.
 Speed to market for customers and support their regulatory requirements.
 Timely delivery and prompt response to all queries of the customers.
2
Key factors & Future Goals:
Company History:
 Promoted by Technocrats
having business experience
Owner ship:
It is a private limited company
 Incorporated in June-2013
in Hyderabad, INDIA-500090
 Focus on Quality ingredients
in a cost effective manner to
the clients
 Assure to comply with global
regulatory requirements
It is a private limited company
held by shares
Facilities and Location(s):
 A state of the art R&D facility in
Hyderabad.
 A leased state of art GMP
manufacturing facility in Bangalore.
3
regulatory requirements
 Expertise in develop a
safe, robust & scalable
process
(NOTE: Our integrated manufacturing
facility suitable for all global
accreditations will be ready by end of
2019)
The Leadership Team:
Mr. JAGAN MOHAN GUNNAM (CEO)
Mr.Jagan is completed M.Sc in Organic Chemistry and had 18 years of Industrial Experience in Synthetic
Chemistry , CRAMS, Medicinal Chemistry & API area in various MNC’s in Hyderabad. He led Laxmi
Genchem through the initial phases of evolution with remarkable success. He is responsible for putting the
right scientific talent, leadership, marketing, business development and infrastructure in place to ensure
continuous growth.continuous growth.
Mrs. PRATHIMA UPPALA (DIRECTOR, ACCOUNTS & FINANCE)
Mrs. Prathima is completed her M.Sc in Organic chemistry, MBA and had 15 years of Experience in
Accounting, Finance, Taxation & Commercial at various industries. She is also expertise and responsible for
HR activities and purchase at Laxmi Genchem Sciences.
Mr. GIREESH JAMPANA (DIRECTOR, QUALITY/ANALYTICAL DEVELOPMENT)
Mr.Gireesh is completed M.Sc in Analytical chemistry and had about16 years of Industrial Experience in the
area of regulatory compliance domains, quality assurance, site monitoring, vendor monitoring in cGLP
environment, monitoring of manufacturing compliance under regulatory guidelines, expertise in method
development and validations for different regulatory submissions.
4
development and validations for different regulatory submissions.
Dr. P.M. AKBAR ALI (CHIEF CONSULTANT-REGULATORY)
Dr. Ali is completed M.Sc, PhD in chemistry, MBA . He has to his credit 25 papers in various national and
international journals and holds 12 patents. He has got professional experience of more than 28 years in
various MNC’s in leadership roles; his last assignment is with M/s. Apotex Pharmachem India Pvt Ltd as a
Managing director.
Chemistry Services at a Glance:
Discovery Chemistry
 Medicinal Chemistry
Process Chemistry
 Route scouting & Non-infringing route selection Medicinal Chemistry
 Focused library design and synthesis
 Scaffold & Building block synthesis
 Metabolite Identification & synthesis
 Route scouting & Non-infringing route selection
 Process Research & Development – Scale up
 cGMP manufacturing of NCEs & Intermediates
 Cost effective process for Generics
 Polymorphism and salt screening
Analytical chemistry
5
 Method development/Validations
 Quality control
 Documentation
 Stability studies
 Regulatory filings
Chemistry Capabilities:
Heterocyclic
Synthesis
Enzymatic
Non-infringing
and cost
Specialized
Capabilities
Enzymatic
Reactions
Chiral ligand or
Auxiliary based
asymmetric
synthesis
Palladium
Intermediates
& Fine
chemicals
and cost
effective route
scouting
6
Palladium
catalyzed and
other
organometallic
reactions
Scale up
Parellel
synthesis and
building block
libraries
Stereo
Isomer
resolution
Process chemistry expertise:
Expertise in hazardous & critical reations
 Cyanation (NaCN & CuCN)
 Carbon monoxide reactions
 Grignard preparation & reactions
 Reducing by using NaBH4 / LiAlH4
 Fridel-craft’s reactions
7
 Fridel-craft’s reactions
 Chlorination (SOCl2, POCl3, HCl)
 High Pressure reactions
State-of-the-Art R&D, Pilot scale and Analytical
Facilities:
Analytical Laboratory
1. HPLC
2. GC
R&D/Pilot scale Laboratory
1. Fume hoods/ Walk in hoods
2. Rotary evaporators2. GC
3. LC-MS (Out source)
4. NMR (Out source)
5. FT-IR
6. UV-VIS spectrophotometer
7. Polarimeter (Out source)
8. K.F Appartus
9. Melting Point Apparatus
10. pH meter
2. Rotary evaporators
3. Weighing scales
4. High Vacuum systems
5. Cryogenic reactors
6. Combiflash
7. Auto clave
8. High pressure reactions
9. High temperature reactions
10. Vacuum dryer
8
 One of the best stand alone facility for high value based products ranging
from Milli gram to Kilo gram level.
 A leased cGMP facility for commercial manufacturing to produce Kilo gram to
Multi ton level.
The commercial facility (leased):
 State of the Art GMP manufacturing facility
 Quality system complying to ICH Q7
 Production block with 12 reactors
 Facility from 900 to 4000 litre capacity
 Kilo lab facility
 Well equipped QC lab
 5000 sq.ft Ware house
9
 ISO 9001:2008 certified company
PROJECT MANAGEMENT:
Initiation Planning Execution Monitoring ClosingInitiation Planning Execution Monitoring Closing
>Dedicated
project
>Micro plan
and schedule
>Work
commencemen
>Progress of the
project
>Evaluation of
project phase
10
project
leader
>Team
formation
>Information
gathering
>Project
overview
and schedule
>Procurement
s
>Communicati
on meetings
with client
commencemen
t
>Sharing of
project
progress
>Meetings with
client
project
>Changes if any
to be taken up
>Quality
inspections
>Weekly updates
project phase
as per
requirement
>Final report
submission
>Closure
meeting
Beyond Delivery-Focus on Value creation
Track
record
Communicati
on
Experience
Expertise
Problem
solving
Automation
11
Delivery
Value creation
Business Terms:
 Fee-for-Service (PO based compound synthesis)
 FTE-based
 Collaborative research
Flexible and creative Price structure
Same focus of Innovation, Impact and Integrity regardless of terms.
12
The Laxmi Genchem Advantage:
Intellectual
Partnership
• Experienced Management
• Integrated drug discovery
capabilities
Low Drug
development
costs
• Competitive Pricing
• Efficient Organization
• Reduced client overhead
13
Value
creation
• Problem solving
• Automation
• Highest Quality
THANK YOU
For more information please contactFor more information please contact
Plot No:90, ALEAP Industrial Estate
Pragathi Nagar, HYDERABAD - 500090.
Telangana, INDIA.
Mobile: +91-9440124136
14
Mobile: +91-9440124136
E-mail: info@laxmigenchem.com
www.laxmigenchem.com

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LGS_Corporate presentation

  • 1. LAXMI GENCHEM SCIENCES SOLUTIONS FOR HEALTHIER LIFE 1
  • 2. About us  Laxmi Genchem Sciences Pvt Ltd is a contract research & generic API manufacturing organization which services global Pharma industry established in 2013; operated in Hyderabad, INDIA. Vision:  Our mission is to focus on business to rapidly assist our partners in development of NCEs & Generic API non-infringing route scouting in a cost effective manner as per global regulatory requirements.  Our team committed to absolute assurance of best quality of Ingredients with a strong regulatory backup. Mission:  Quality requirements as per ICH guidelines.  Speed to market for customers and support their regulatory requirements.  Timely delivery and prompt response to all queries of the customers. 2
  • 3. Key factors & Future Goals: Company History:  Promoted by Technocrats having business experience Owner ship: It is a private limited company  Incorporated in June-2013 in Hyderabad, INDIA-500090  Focus on Quality ingredients in a cost effective manner to the clients  Assure to comply with global regulatory requirements It is a private limited company held by shares Facilities and Location(s):  A state of the art R&D facility in Hyderabad.  A leased state of art GMP manufacturing facility in Bangalore. 3 regulatory requirements  Expertise in develop a safe, robust & scalable process (NOTE: Our integrated manufacturing facility suitable for all global accreditations will be ready by end of 2019)
  • 4. The Leadership Team: Mr. JAGAN MOHAN GUNNAM (CEO) Mr.Jagan is completed M.Sc in Organic Chemistry and had 18 years of Industrial Experience in Synthetic Chemistry , CRAMS, Medicinal Chemistry & API area in various MNC’s in Hyderabad. He led Laxmi Genchem through the initial phases of evolution with remarkable success. He is responsible for putting the right scientific talent, leadership, marketing, business development and infrastructure in place to ensure continuous growth.continuous growth. Mrs. PRATHIMA UPPALA (DIRECTOR, ACCOUNTS & FINANCE) Mrs. Prathima is completed her M.Sc in Organic chemistry, MBA and had 15 years of Experience in Accounting, Finance, Taxation & Commercial at various industries. She is also expertise and responsible for HR activities and purchase at Laxmi Genchem Sciences. Mr. GIREESH JAMPANA (DIRECTOR, QUALITY/ANALYTICAL DEVELOPMENT) Mr.Gireesh is completed M.Sc in Analytical chemistry and had about16 years of Industrial Experience in the area of regulatory compliance domains, quality assurance, site monitoring, vendor monitoring in cGLP environment, monitoring of manufacturing compliance under regulatory guidelines, expertise in method development and validations for different regulatory submissions. 4 development and validations for different regulatory submissions. Dr. P.M. AKBAR ALI (CHIEF CONSULTANT-REGULATORY) Dr. Ali is completed M.Sc, PhD in chemistry, MBA . He has to his credit 25 papers in various national and international journals and holds 12 patents. He has got professional experience of more than 28 years in various MNC’s in leadership roles; his last assignment is with M/s. Apotex Pharmachem India Pvt Ltd as a Managing director.
  • 5. Chemistry Services at a Glance: Discovery Chemistry  Medicinal Chemistry Process Chemistry  Route scouting & Non-infringing route selection Medicinal Chemistry  Focused library design and synthesis  Scaffold & Building block synthesis  Metabolite Identification & synthesis  Route scouting & Non-infringing route selection  Process Research & Development – Scale up  cGMP manufacturing of NCEs & Intermediates  Cost effective process for Generics  Polymorphism and salt screening Analytical chemistry 5  Method development/Validations  Quality control  Documentation  Stability studies  Regulatory filings
  • 6. Chemistry Capabilities: Heterocyclic Synthesis Enzymatic Non-infringing and cost Specialized Capabilities Enzymatic Reactions Chiral ligand or Auxiliary based asymmetric synthesis Palladium Intermediates & Fine chemicals and cost effective route scouting 6 Palladium catalyzed and other organometallic reactions Scale up Parellel synthesis and building block libraries Stereo Isomer resolution
  • 7. Process chemistry expertise: Expertise in hazardous & critical reations  Cyanation (NaCN & CuCN)  Carbon monoxide reactions  Grignard preparation & reactions  Reducing by using NaBH4 / LiAlH4  Fridel-craft’s reactions 7  Fridel-craft’s reactions  Chlorination (SOCl2, POCl3, HCl)  High Pressure reactions
  • 8. State-of-the-Art R&D, Pilot scale and Analytical Facilities: Analytical Laboratory 1. HPLC 2. GC R&D/Pilot scale Laboratory 1. Fume hoods/ Walk in hoods 2. Rotary evaporators2. GC 3. LC-MS (Out source) 4. NMR (Out source) 5. FT-IR 6. UV-VIS spectrophotometer 7. Polarimeter (Out source) 8. K.F Appartus 9. Melting Point Apparatus 10. pH meter 2. Rotary evaporators 3. Weighing scales 4. High Vacuum systems 5. Cryogenic reactors 6. Combiflash 7. Auto clave 8. High pressure reactions 9. High temperature reactions 10. Vacuum dryer 8  One of the best stand alone facility for high value based products ranging from Milli gram to Kilo gram level.  A leased cGMP facility for commercial manufacturing to produce Kilo gram to Multi ton level.
  • 9. The commercial facility (leased):  State of the Art GMP manufacturing facility  Quality system complying to ICH Q7  Production block with 12 reactors  Facility from 900 to 4000 litre capacity  Kilo lab facility  Well equipped QC lab  5000 sq.ft Ware house 9  ISO 9001:2008 certified company
  • 10. PROJECT MANAGEMENT: Initiation Planning Execution Monitoring ClosingInitiation Planning Execution Monitoring Closing >Dedicated project >Micro plan and schedule >Work commencemen >Progress of the project >Evaluation of project phase 10 project leader >Team formation >Information gathering >Project overview and schedule >Procurement s >Communicati on meetings with client commencemen t >Sharing of project progress >Meetings with client project >Changes if any to be taken up >Quality inspections >Weekly updates project phase as per requirement >Final report submission >Closure meeting
  • 11. Beyond Delivery-Focus on Value creation Track record Communicati on Experience Expertise Problem solving Automation 11 Delivery Value creation
  • 12. Business Terms:  Fee-for-Service (PO based compound synthesis)  FTE-based  Collaborative research Flexible and creative Price structure Same focus of Innovation, Impact and Integrity regardless of terms. 12
  • 13. The Laxmi Genchem Advantage: Intellectual Partnership • Experienced Management • Integrated drug discovery capabilities Low Drug development costs • Competitive Pricing • Efficient Organization • Reduced client overhead 13 Value creation • Problem solving • Automation • Highest Quality
  • 14. THANK YOU For more information please contactFor more information please contact Plot No:90, ALEAP Industrial Estate Pragathi Nagar, HYDERABAD - 500090. Telangana, INDIA. Mobile: +91-9440124136 14 Mobile: +91-9440124136 E-mail: info@laxmigenchem.com www.laxmigenchem.com