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Tender Value
Refer Docs
Closing Date
23 Sept 2021, 11:30 amClosed
Director CSIR-IIIM Jammu
CSIR-IIIM Jammu
GMP Manufacturing of New Chemical Entity (IND Candidate- IIIM 290) and capsule formulation for FIH clinical studies.
2021_CSIR_87868_1
12(318)/21-P
Open Tender
Miscellaneous Services
Supply
120 days
CSIR-IIIM Canal Road Jammu
Please refer Tender documents.
5 documents required · 5 mandatory
₹0
Exempted
30 Sept 2021
10 Sept 2021
24 Sept 2021
10 Sept 2021
23 Sept 2021
10 Sept 2021
GMP Manufacturing of New Chemical Entity (IND candidate –IIIM 290) and capsule formulation for FIH clinical studies. • IIIM-290 is the anticancer NCE (Cdk9 inhibitor) discovered by IIIM< for which DCGI approval to conduct FIH clinical trial is already received. • The detail of API synthesis, formulation manufacturing, list of raw materials, KSMs are provided in a separate sheet. • Pricing to be quoted separately for each activity mentioned below as the order may be placed activity-wise.
ACTIVITY#1:
ACTIVITY#1: Synthesis of active pharmaceutical ingredient (New Chemical Entity) under certified Good Manufacturing Practices, Complete CMC and stability studies of API as per regulatory requirements (NCE requirements specified by CDSCO) to be done by the firm. • Quantity:[350g X 3 batches =1050g]. • Raw materials, KSMs to be procured by the quoting firm. • The reference standards of API, impurities, intermediates shall be supplied by the sponsor. • Validated analytical method is already available with the sponsor, same to be used by the firm for CMC documentation. • Documents required by sponsor: DMF and Form-29 license.
ACTIVITY#2:
ACTIVITY#2: Manufacturing of capsule formulation of the active pharmaceutical ingredient ( New Chemical Entity-IIIM 290). Complete CMC and stability studies of formulation as per regulatory requirements (formulation /product requirements specified by CDSCO) to be done by the firm. • Quantity :[ 3500 capsules X 3 batches = 10500 capsules] • Raw materials, KSMs to be procured by the quoting firm. • The API will be supplied by the sponsor (if the API synthesis is not done a the same firm). • Validated analytical mehtos is already available with the sponsor. Same to be used by the firm for CMC documentation.
VACHICHEM INTERNATIONAL PRIVATE LIMITED
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