Contract Manufacturing Services

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Contract Manufacturing Services
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GVK BIO offers long term Contract Manufacturing
services right from strategic partnerships in
development, validations, DMF filing and
commercial manufacturing of Active Pharmaceutical
Ingredients (APIs)/advanced intermediates to
APIs. We have flexible business models to support
various client needs

1. Process optimisation, technology transfer,
   validations and DMF filing followed by
   manufacturing upon commercialization.
2. Technology absorption, validations, DMF filing
   support and Commercial manufacturing.
3. Technology absorption and commercial
   manufacturing.

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We have a diverse scientific team with expertise
to meet API and advanced intermediate needs
centred on the rapid synthesis of supplies. Our
project management and technical teams ensure a
seamless technology transfer of processes, as
projects advance from feasibility to DMF filing
through complete process optimisation, process
validations and stability program. We can
optimise and develop robust and cost efficient
processes for large scale manufacturing using
environment friendly routes under GMP conditions
with globally acceptable regulatory guidelines.
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The combination of development experience,
manufacturing infrastructure and regulatory
expertise makes GVK BIO a preferred strategic
partner for reliable, cost effective, long term
contract manufacturing partners for APIs/advanced
intermediates.
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GVK BIOs manufacturing facility has approvals
from worldwide regulatory authorities like USFDA,
EDQM, PMDA, KFDA and WHO GMP. These
accreditations facilitate faster and easier
approvals of DMFs/dossiers for our business
partners.

• Our dedicated late stage development teams have
  extensive experience in the following
• Commercial synthesis route scouting
• Commercial process development and optimisation
  through DoE and QbD
• Stepwise unit operation studies and defining
  critical process parameters
• Impurity profiling and define control measures
• Documentation for all kinds of regulatory filings

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Our commercial manufacturing facility is
co-located with our pilot plant, providing
end-to-end API service from feasibility phase in
RD to commercial launch. This integration
eliminates the need for tech transfers when a
project advances through each development phase,
allowing us to help reduce delivery time while
providing cost-effective services. Our
facilities can scale up all types of reactions,
including asymmetric hydrogenations, air and
water sensitive metal catalytic reactions, high
temperature, high pressure, cryogenic and
oxidations reactions.
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• The manufacturing facility has wide range of
  equipment
• Reaction vessels starting from capacity 20 L to
  6000 L
• Material of construction stainless steel, glass
  lined, glass, halar coated, hastelloy-C, etc.
• Utilities ranging from -70C to 200C
• Supporting equipment to handle all kinds of unit
  operations

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• GVK BIOs manufacturing team has expertise to
  handle a wide range of operating conditions with
  flexible scales. Over the years we have exhibited
  exemplary process and technology capabilities for
  NCEs and commercial production of advanced
  intermediates/APIs. Our process development,
  technology transfer and commercial execution
  teams collaborate seamlessly to provide
  best-in-class concept to commercialisation
  timelines.
• Salient features
• Driven by the need to design an economic and
  robust process with defined in-process controls
  to yield optimum and desired quality
• Provide engineering support from initial stages
  of product development by identifying process
  specific facility requirements to deliver a
  validated process at designated scale
• Observe and assimilate process operations and all
  critical parameters and systematically execute
  under guidelines charted by Quality Management
  Systems

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• Manufacturing Infrastructure
• GMP compliant six manufacturing blocks with
  varied capacities ranging from 20 L 6,000 L
• Total reaction volume capacity 170,000 L
• MOC All glass, glass lined, SS Hastelloy
  reactors
• Hydrogenation capabilities 50 L to 2,000 L, upto
  25 bar and large scale column chromatography
• Class 100,000 cleanroom, kilo labs and powder
  processing area
• Stability chambers for conducting stability
  studies at all conditions

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About GVK BIO

• Established in 2001, GVK BIO is one of Asias
  leading life sciences service organizations. At
  GVK BIO, we blend science with people and
  technology to help accelerate drug discovery and
  development for more than 400 clients globally
  across small and large molecule platforms. Our
  clients include the worlds top 10 corporations
  in the field of Pharmaceutical, Biotechnology and
  Agrochemicals along with leading Academic
  institutions.

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