Research & Development

  • Highly skilled and diverse team comprising of PhD’s, Postgraduates and Chemical Engineers
  • Expertise in handling multi-step complex chemistry, extended coupling reactions, stereoselective and chiral complex products
  • Full-scale patent evaluation & developing non-infringing processes
  • Collaborative Programs under confidentiality agreements
  • Development & Validation of test methods and Genotoxic Impurities evaluation
  • Air Jet mill Micronizer and Multi-mill
  • Purified water system to meet current USP quality

Chemical Research and development (CRD) Infrastructure and capabilities

  • Well-equipped R&D centers located at Bhondsi, Gurugram, Haryana, Approved by Department of Scientific and Industrial Research, Ministry of  Science & Technology Government of India
  • Highly competent Process Chemistry group supported by highly experienced and competent Analytical Development team, Regulatory Affairs, Intellectual Property, engineering Technology development and transfer, Technology improvement and Impurity teams
  • The infrastructure includes research and scale-up utilizing latest state of the art micro channel reactor technology, utilization of green technologies like use of enzymes for several products, high pressure hydrogenators, use of software for Design of experiments to focus on Quality by design
  • Full-fledged research laboratory for innovation & optimization in API manufacturing process & engineering

Analytical Research and development (ARD) infrastructure and capabilities

  • Well equipped with sophisticated advance analytical instrumentations with 21 CFR part 11 compliant
  • For development, sample Stability Studies are being performed as per ICH guidelines for following conditions
    • Long term Condition 25 C/ 60% RH
    • Intermediate Condition 30 C/ 75% RH. Zone IV
    • Accelerated Condition 40 C / 75% RH
  • Analytical Method Development & Validation as per ICH guideline recommendation to meet worldwide regulatory requirements
Genotoxic Impurities evaluation for Drug Substances along with analytical method development and validation to meet worldwide regulatory agencies requirements.

Manufacturing operations

  • Multi-product cGMP manufacturing units. 
  • Five powder processing areas as per class ISO 8 (Class 100,000)
  • Reaction Temperature ranging from -90°C to +220°C
  • Blenders with 300 L to 3000 L volume
  • High vacuum distillation at 1 Torr and high-pressure reactions at 20 Bar in combination of 200°C temperature
  • Installed reaction capacity of 214,000 L with 68 reactors-31 SSR, 36 GLR, One Cryogenic reactor, ranging from 100 L to 8,000 L
  • 15 Centrifuges - (24-60”) stainless steel, halar-coated and peeler
  • 18 Dryers : RCVD, VTD, FBD, ANFD, TD and Nauta
  • Air Jet mill Micronizer and Multi-mill
  • Purified water system to meet current USP quality

The Reactors

The Utility Equipment

Other Equipment


  • We are committed to constantly improve the quality standards of our products and services by implementation of cGMP, up-gradation in technology; imparting training to effectively adapt to newer technologies and high standard
  • Well equipped 21 CFR compliant Instrumentation & Microbiology labs

Quality Control

Raw material section

Vendor sample analysis and innovation

Documentation section

Ensuring availability of effective documents on shop floor and retrieval of obsolete documents to prevent usage

Finished goods section

Manufactured products tested for usage and dispatch

Stability section

Stability studies to establish the shelf life and storage condition of active pharmaceutical ingredients and holding time for intermediates

Instrumentation section

Analysis by applicable quality attributes, analytical data provided to RM or FG section for compilation and conclusion

GLP section

Periodic calibration and preventive maintenance of instruments as per schedule

Quality assurance

  • It is the totality of the arrangements made with the object ensuring that pharmaceutical products are of the required quality for their intended use
  • A dynamic process - journey towards the destination
  • The heart and soul of quality control


  • To achieve the quality objective reliably there must be comprehensively designed and correctly implemented system of Quality Assurance incorporating GMP & quality control
  • It should be fully documented & effectiveness monitored
  • All parts of quality assurance system should be adequately staffed with competent personnel and should have suitable and sufficient premises, equipment and facilities

    Quality Management
  • Initiation & Approval of Procedures
  • Coordination and approvals of validations and qualifications protocols and reports
  • Review and compliance of all Documents
  • Change control & Deviation
  • On job training and Training on GMP topics
  • Investigation (Root Cause analysis) & CAPA
  • Handling of Customer complaints 
  • QA release and Dispatched 
  • Self inspection 
  • Vendor qualifications 
  • Annual product review 
  • Management reviews

Regulatory compliance

Regulatory Affairs

Driving innovation to market success! 

  • Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization
  •  It serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product
  • It is the responsibility of RA to keep abreast of current legislation, guidelines and other regulatory intelligence


  • To obtain approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market
  • To contribute to designing the development program
  • To review all documentation from a regulatory perspective, ensuring that it is clear, consistent and complete, and that its conclusions are explicit
  • To provide inputs when legislative changes are being discussed and proposed


Intellectual Property: 

India: Currently we have filed nine patent applications on various API projects

PCT:  Filings are in process

  1. The Company had filed an application for grant of patent for the improved process for the preparation of AP! product Luliconazole on 2nd January 2023 vide application number PCT/IN2023/050001 to World Intellectual Property Organization (WIPO) / Patent Cooperation Treaty (PCT).

974, Aggarwal Millennium Tower II,
Netaji Subhash Place, Pitampura,
New Delhi-110 034
+91-11-4706 3600

Kimia Biosciences Ltd™ is engaged in manufacturing of bulk drugs addressing to various high potential therapeutic segments and has envisaged high growth plans through infrastructure creation and CMS.