Infrastructure and Capabilities

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Infra & Capabilities

Infrastructure

95,000 sqmts
1st production block is under construction (total plan is for 2 blocks)
total 35000 lit capacity
Reactors from 6KL to 1KL
Regulatory Approvals
Production to be started from AUG-2025

Research and development

Our team of highly qualified research scientists bring in depth of knowledge and experience to our engagements. Fleming R&D centre is accredited by the Government of India (DSIR).

8 member R&D team led by senior R&D professionals
Dedicated Infrastructure with 8 fume hoods (Expansion to 16 fume hoods in progress)
Capability to handle wide range of chemistries
Strong IP knowledge
Integrated tech transfer and EHS risk assessment team
Expertise in process development, impurity profiling, synthesis and characterization
Expertise in Regulatory Query resolutions
Expertise in current regulatory expectations like Genotoxic impurities assessment, Nitrosamine impurities assessment, etc.

Objective

Develop environmentally friendly and safe processes
Quick turnaround time (product identification to market)
Development of robust processes (detailed stress studies on process parameters)

Manufacturing

Our highly experienced manufacturing team ensures that we deliver the right quality product in time.

Our Manufacturing Capabilities Includes:

Highly experienced manufacturing and Engineering team
Robust planning process driven by customer demand
Wide range of process equipment supporting the chemistries handled
Wide range of Utility equipment to support the critical process parameters
Zero liquid discharge effluent treatment system

Objective

Delivering the products, on-time to the customers
Operational excellence through continuous improvement
Zero accidents and incidents

Quality Management

Quality Assurance

Quality management system and documentation in line with ICH
System backed up by continuous training of personnel
Regular Internal Quality Audits and supplier audits to ensure that products meet quality consistently

Quality Control

Well trained and experienced team
Comprehensive and integrated analytical capability
Electronic data management as per 21CFR part 11

Objective

Do it right the first time every time
Zero market complaint

Regulatory Support

Regulatory Capabilities:

Preparation of DMFs
Filing variations & updates
Response to deficiencies within stipulated timelines

Objective

Response in time

We Provide Advanced Laboratory & Analytical Solutions

A dynamic stream of scientific innovation flows through our lab—driving precision technologies and empowering intelligent, data-driven discoveries.

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