Laxmi Genchem Sciences Pvt Ltd is contract research & generic API manufacturing organization that services global pharma industry; is operated in Hyderabad, INDIA. Established in 2013, has a rich experience in a focused business to rapidly assist our partners in development of NCEs & Generic API non-fringing route scouting; will support the commercial manufacturing with all global regulatory requirements;A Global company in its aspiration with a focus on all stake holders, the employees, the customers and finally the consumers of the products (finished dosages) that carry our quality Ingredients.
Creating knowledge, building strong intellectual base, cultivating an environment with values such as respect, diligence and strong sense of creativity shall be our hallmarks.
Visit us:
www.laxmigenchem.com
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.
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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.
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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.
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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
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Method development/Validations
Quality control
Documentation
Stability studies
Regulatory filings
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
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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
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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
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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
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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
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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.
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13. The Laxmi Genchem Advantage:
Intellectual
Partnership
• Experienced Management
• Integrated drug discovery
capabilities
Low Drug
development
costs
• Competitive Pricing
• Efficient Organization
• Reduced client overhead
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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
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Mobile: +91-9440124136
E-mail: info@laxmigenchem.com
www.laxmigenchem.com