Intermediate, API and Drug product solutions
Company profile
DHI Pharmaceutical, located in Baroda, India. Set up in June 2018, DHI offers a broad spectrum of services that include
Custom Research & Development, Custom Synthesis, Contract Manufacturing and Commercial Manufacturing, while also
intelligently managing and offering Intermediates & Bulk Actives (API) to a large base of clients globally
Mission
To innovatively support the global pharmaceutical industry in Process R&D, Custom synthesis, Contract manufacturing and
also intelligently manage the Intermediates & Bulk actives (API) segment.
Providing Scientific Edge
The capabilities and expertise of our scientists match the most exacting International Standards. Backed by outstanding
academic credentials, core domain knowledge and proven track records, they bring rich industry expertise and global
experience to our service offering.
Enduring Partnerships
We are committed to maintaining open and transparent communication that fosters long term partnerships. We take the
time and effort to understand preferences and working styles, so our clients maximize the benefits from collaboration.
Complete Confidentiality
Our clients trust us completely with their proprietary information. Whether it is a FTE (Full Time Equivalent) based
partnership of process R&D or a FFS (Fee for Service) based custom manufacturing program, sensitivity to client
confidentiality permeates all our operations.
Services
The Process Research & Development (PRD) support offering is a Full Time Equivalent (FTE) model. The service
model is designed to address typical requirements of an FTE collaboration addressing both the scientific and
communication challenges. DHI understands that customization is the key to perform and progress in a collaborative
relationship.
Process R&D and Custom Chemical Synthesis
Process R&D
• Route scouting
• Feasibility studies
• Optimization
• Synthetic demonstration
• Large scale manufacturing
• Salt screening
• Polymorph studies
Custom Chemical Synthesis
• Process development & Optimization
• Piloting and Scale-up
• Validations
• Impurities – Identification,
characterization and synthesis
• Process development Report
• GMP manufacturing
Technology Transfer - An Integral Part of Development
Process
• Identifying major risks / scale-up
Capabilities
• Estimation of manufacturing expenses
• Estimation of timelines with available
tech-pack
• Identifying new infrastructural
• requirements
Development
• Being integral part of development
Identifying critical parameters &
initiating “what-if” studies
• Identifying likely scale-up issues &
planning experiments for further
studies Quality & safety risk
assessment
Scale-up / Piloting
• Hazop study & risk assessment as
mandatory task
• Equipment mapping in discussion with
pilot plant & manufacturing
• Initiate technology transfer as per the
check list.
• Being part of execution team for
• Piloting along with R&D
Closure
• Making campaign report Identifying
improvement opportunities for further
campaign
• Capturing learning at each phase of
project as summary
Our quality assurance department, supported by regulatory affairs and quality control groups, monitors the work performed in
our facility. All projects related to APIs are managed by comprehensive GMP compliant systems. The GMP system is developed
using references from the FDA, ICH guidelines, USP and CFR.
DHI is committed to:
† Consistently meeting or exceeding quality requirements of customers
† Continual improvement of systems and processes
† Ensuring proper training of employees for better performance
† Recognizing that quality is not just another goal, but a necessity for sustained growth
Intellectual Property
DHI follows a ‘no-conflict’ research model. Any intellectual property generated during the course of a project belongs to the
client, thereby protecting the long term business interests of the client.
GMP compliant Operations
Quality Policy
