CSIR-Central Drug Research Institute, Lucknow is a premier Research Institute of India

pursuing a vision to strengthen and advance the field of drug discovery and development in
the country. It is planning to initiate Phase I Clinical Trials of its lead molecules.The Institute
wishes to outsource cGMP manufacture of these Investigational New Drugs (IND-APIs) and
their oral formulations(tablets/capsules) in market-intended packaging; for the purpose of
“testing, analysis and clinical trials” conforming to the New Drugs and Clinical Trial Rules
2019 and The Drugs and Cosmetics Act 1940 and Rules 1945 as amended.

This Expression of Interest (EOI) invites applications for empanelment of Service Providers
with a proven track record in providing one or more of the services listed below:

1. cGMP synthesis in the range of 1-5 kilogramsof small-moleculesunder a

validmanufacturing license.
2. Providing material (API and / or formulation) for clinical trials as per CDSCO
requirements,produced in cGMP-compliant facility, market-intended packaging and
necessary certifications of compliance with batch-release specifications.
3. Process and Analytical method validation of the APIand / or formulation.
4. Impurity profiling, OVI estimation of API and stability studies of API and / or
formulation in market-intended packaging.
5. The product deliverables include cGMP Audit Trail and documentation such as
Certificate of Analysis and Material Safety Data Sheetas well as packaging details for
API and formulation,and a copy of a valid cGMP certificate.
6. CSIR-CDRI will provide assistance in the application process for obtaining necessary
permissions and approvals from competent authorities.

General information / conditions / instruction to prospective bidders:

The scope of work includes cGMP manufacturing of API and / or formulation of identified
CDRI lead compounds for testing, analysis and clinical trials; generation of Chemical and
Pharmaceutical Information for obtaining regulatory approvals. Interested Firmswith relevant
experience may please sign a Confidential Data Disclosure Agreement with CSIR-CDRI for
obtaining details of the API (such asKey Starting Materials and process of synthesis on
laboratory scale), and suggested dosage forms (excipients, processes).

The applicant should meet the following pre-qualification criteria given below and is required
to submit all supporting documents relating to the credentials / technical capabilities and
track record along with their EOI.

a) Name of the applicant, with their constitution/proprietorship/partnership details etc.

with the date of establishment/registration. Please submit the Articles of Association
with the application.

b) List of similar work / services provided successfully with minimum 2 years experience
in CSIR labs, Government organizations other than CSIR and to Private Agencies
along with brief details of the work. Enclose relevant document / certificate to
ascertain the satisfactory completion of the work / service provided.

c) Valid cGMP certificate on the date of submission of the bid.

Applications in response to this EOI should be submitted online as per prescribed format at
www.etenders.gov.in. The details of this EOI notice is also available on institute website
(www.cdri.res.in).