unit 1: bonthapally, hyderabad unit 2: pashamylaram
TRANSCRIPT
www.neulandlabs.com
PEPTIDESCMSAPIs
India Corporate O�ce | Tel: +91 40 3021 1600India Mumbai O�ce | Tel: +91 22 4004 6035Japan O�ce | Tel: +81 3 3526 5171USA O�ce | Tel: +1 888 617 9587
Unit 1: Bonthapally, Hyderabad● Built up area: 45,325 m2
● 7 production blocks: 3875 m2 production area● 3 Kilo Labs, 4 Warehouses● Total Reactor volume: 175.47 KL● Reaction Temperature: -20°C to 200°C
Unit 2: Pashamylaram, Hyderabad● Built up area: 36,800 m2
● 6 production blocks: 3250 m2 production area● Mini plant for scaling up of new products● Total Reactor volume: 300.10 KL● Reaction Temperature: 40°C to 150°C
Our Manufacturing Facilities
Company Pro�le & Infrastructure
An Overview of Neuland
CompanyPro�le andInfrastructure
www.neulandlabs.com
Neuland is a no-compromise, pharmaceutical services provider, o�ering worldwide compliantmanufacturing facilities to its customers which it guarantees not to compete with in �nished product.
“
”Facilities Certi�cation
Authority Unit 1 (Year) Unit 2 (Year)
USFDA (USA) 1997, 2004, 2008, 2010, 2014 1999, 2002, 2005, 2012, 2015
EDQM (Europe) 2005 –
EMA (Europe) 2013 _
PMDA (Japan) 2008 2008
TGA (Australia) – 2011
BfArM (Germany) – 2007
AFSSAPS (France) – 2012
ANVISA (Brazil) 2012, 2014 2011, 2013
COFEPRIS (Mexico) 2014 2014
KFDA (South Korea) 2010, 2014 2012
WHO GMP 2015 2015
ISO 14001:2004 2013 2013
OHSAS 18001:2007 2013 2013
ISO 9001:2008 2014 2014
ISO 27001:2013 2015 2015
Company Pro�le & Infrastructure
History: Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. Our main business is manufacturing of API's and advanced intermediates from our FDA approved facilities and we are end-to-end solution provider for the pharmaceutical industry for chemistry related services from synthesis of library compounds to supply NCEs and intermediates at various clinical phases up to commercial scale.
For over 30 years, Neuland has been at the forefront of facilitating and accelerating drug development and cGMP manufacturing of APIs. The Company’s technical and scienti�c teams provide reliable solutions and services to the global pharmaceutical industry.
Employees: Over 1000 employees, 200 scientists with over 31 Ph.Ds. in the R&D Centre.
Promoters and Management team: The Company is led by Dr D R Rao who has around 41 years of industry experience. Management reports to the Board of Directors, which has leading practioners form various segments of the industry.
Brief Overview
Business Verticals
APIs: The Company’s core business and operational expertise since inception has been the manufacturing of Active Pharmaceutical Ingredients (APIs). Neuland has earned the identity of a preferred and reliable source in the pharmaceutical industry primarily due to:
● Consistency in product quality● Knowledge and ability to deal with niche chemistry● On-time delivery performance
Neuland has 2 US FDA and EU GMP compliant manufacturing facilities with collective capacity of 480 KL to produce more than 75 APIs across 10 diverse therapeutic areas.
Custom Manufacturing Solutions: Neuland’s Custom Manufacturing Solutions (CMS) derives from its proven expertise in chemical process development to manufacturing at varied scales, a deep understanding of complex chemical processes and manufacturing. Its facilities are compliant as per cGMP requirement and meeting environment and safety standards.
Peptides: The Company is currently a supplier of high quality Peptide building blocks like Pseudoproline Dipeptides and other complex Fmoc building blocks. The Company plans to enter into GMP manufacturing of Peptide APIs in the near future.
Our Peptide Synthesis Services include production of peptides from milligrams to multi-kilogram scale by standard sequential chemical peptide synthesis and segment condensation strategies.
www.neulandlabs.comAPIs | CMS | Peptides
Development● 12 Development Labs● 60 Fume Hoods● Analytical Lab● Kilo Labs dedicated for scale up● Dedicated labs for Peptides● GMP pilot plant with 2 production areas● 0.5 -50 kg batch size● Separate facility for D2 analogues
Analytical Infrastructure● 300 MHz FT NMR (Bruker)● LC-MS-MS (Waters) ● GC-MS (Perkin Elmer)● XRD (PANalytical)● ICPMS● HPLC with UV/PDA/ RI Detectors (Waters)● FT-IR (Perkin Elmer)● UV Visible Spectrophotometer (Perkin Elmer)● Preparatory HPLC (Waters)● Particle Size Analyzer (Malvern)● DSC (Perkin Elmer)● Digital Polarimeter● TGA (Perkin Elmer)
Neuland has a dedicated 40,000 sq.ft. R&D centre located near Hyderabad. Our highly experienced and quali�ed R&D sta� comprises of over 200 scientists educated in India, US and Europe. Our R&D Centre, Pilot Plant and Kilo Labs are suited for performing
a variety of reactions over broad temperature ranges. Neuland’s customers have successfully launched many complex molecules e�ciently as a result of Neuland’s ability to develop non-infringing processes and its superior diverse knowledge and expertise.
Research and Development Centre
R&D Facilities
Our Growth Story1984Incorporation ofNeuland Labs
1986First API saleof salbutamol
1994Neuland’sIPO
1997First USFDAinspection
2004US subsidiaryincorporated
2008ISMS approval,SAP enabled
2009PMDA, Japanapproval
2010First Peptidecollaboration
2007Japan subsidiary,JV with Cato Research
2009First NCEapproval
2013MAPICCollaboration
201510th FDAinspection
Company Pro�le & Infrastructure
History: Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. Our main business is manufacturing of API's and advanced intermediates from our FDA approved facilities and we are end-to-end solution provider for the pharmaceutical industry for chemistry related services from synthesis of library compounds to supply NCEs and intermediates at various clinical phases up to commercial scale.
For over 30 years, Neuland has been at the forefront of facilitating and accelerating drug development and cGMP manufacturing of APIs. The Company’s technical and scienti�c teams provide reliable solutions and services to the global pharmaceutical industry.
Employees: Over 1000 employees, 200 scientists with over 31 Ph.Ds. in the R&D Centre.
Promoters and Management team: The Company is led by Dr D R Rao who has around 41 years of industry experience. Management reports to the Board of Directors, which has leading practioners form various segments of the industry.
Brief Overview
Business Verticals
APIs: The Company’s core business and operational expertise since inception has been the manufacturing of Active Pharmaceutical Ingredients (APIs). Neuland has earned the identity of a preferred and reliable source in the pharmaceutical industry primarily due to:
● Consistency in product quality● Knowledge and ability to deal with niche chemistry● On-time delivery performance
Neuland has 2 US FDA and EU GMP compliant manufacturing facilities with collective capacity of 480 KL to produce more than 75 APIs across 10 diverse therapeutic areas.
Custom Manufacturing Solutions: Neuland’s Custom Manufacturing Solutions (CMS) derives from its proven expertise in chemical process development to manufacturing at varied scales, a deep understanding of complex chemical processes and manufacturing. Its facilities are compliant as per cGMP requirement and meeting environment and safety standards.
Peptides: The Company is currently a supplier of high quality Peptide building blocks like Pseudoproline Dipeptides and other complex Fmoc building blocks. The Company plans to enter into GMP manufacturing of Peptide APIs in the near future.
Our Peptide Synthesis Services include production of peptides from milligrams to multi-kilogram scale by standard sequential chemical peptide synthesis and segment condensation strategies.
www.neulandlabs.comAPIs | CMS | Peptides
Development● 12 Development Labs● 60 Fume Hoods● Analytical Lab● Kilo Labs dedicated for scale up● Dedicated labs for Peptides● GMP pilot plant with 2 production areas● 0.5 -50 kg batch size● Separate facility for D2 analogues
Analytical Infrastructure● 300 MHz FT NMR (Bruker)● LC-MS-MS (Waters) ● GC-MS (Perkin Elmer)● XRD (PANalytical)● ICPMS● HPLC with UV/PDA/ RI Detectors (Waters)● FT-IR (Perkin Elmer)● UV Visible Spectrophotometer (Perkin Elmer)● Preparatory HPLC (Waters)● Particle Size Analyzer (Malvern)● DSC (Perkin Elmer)● Digital Polarimeter● TGA (Perkin Elmer)
Neuland has a dedicated 40,000 sq.ft. R&D centre located near Hyderabad. Our highly experienced and quali�ed R&D sta� comprises of over 200 scientists educated in India, US and Europe. Our R&D Centre, Pilot Plant and Kilo Labs are suited for performing
a variety of reactions over broad temperature ranges. Neuland’s customers have successfully launched many complex molecules e�ciently as a result of Neuland’s ability to develop non-infringing processes and its superior diverse knowledge and expertise.
Research and Development Centre
R&D Facilities
Our Growth Story1984Incorporation ofNeuland Labs
1986First API saleof salbutamol
1994Neuland’sIPO
1997First USFDAinspection
2004US subsidiaryincorporated
2008ISMS approval,SAP enabled
2009PMDA, Japanapproval
2010First Peptidecollaboration
2007Japan subsidiary,JV with Cato Research
2009First NCEapproval
2013MAPICCollaboration
201510th FDAinspection
www.neulandlabs.com
PEPTIDESCMSAPIs
India Corporate O�ce | Tel: +91 40 3021 1600India Mumbai O�ce | Tel: +91 22 4004 6035Japan O�ce | Tel: +81 3 3526 5171USA O�ce | Tel: +1 888 617 9587
Unit 1: Bonthapally, Hyderabad● Built up area: 45,325 m2
● 7 production blocks: 3875 m2 production area● 3 Kilo Labs, 4 Warehouses● Total Reactor volume: 175.47 KL● Reaction Temperature: -20°C to 200°C
Unit 2: Pashamylaram, Hyderabad● Built up area: 36,800 m2
● 6 production blocks: 3250 m2 production area● Mini plant for scaling up of new products● Total Reactor volume: 300.10 KL● Reaction Temperature: 40°C to 150°C
Our Manufacturing Facilities
Company Pro�le & Infrastructure
An Overview of Neuland
CompanyPro�le andInfrastructure
www.neulandlabs.com
Neuland is a no-compromise, pharmaceutical services provider, o�ering worldwide compliantmanufacturing facilities to its customers which it guarantees not to compete with in �nished product.
“
”Facilities Certi�cation
Authority Unit 1 (Year) Unit 2 (Year)
USFDA (USA) 1997, 2004, 2008, 2010, 2014 1999, 2002, 2005, 2012, 2015
EDQM (Europe) 2005 –
EMA (Europe) 2013 _
PMDA (Japan) 2008 2008
TGA (Australia) – 2011
BfArM (Germany) – 2007
AFSSAPS (France) – 2012
ANVISA (Brazil) 2012, 2014 2011, 2013
COFEPRIS (Mexico) 2014 2014
KFDA (South Korea) 2010, 2014 2012
WHO GMP 2015 2015
ISO 14001:2004 2013 2013
OHSAS 18001:2007 2013 2013
ISO 9001:2008 2014 2014
ISO 27001:2013 2015 2015