DCGI definition
Examples of DCGI in a sentence
Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards, including manufacturing standards promulgated by the Drug Controller General of India (DCGI) (“Minimum Quality Standards”); and (ii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.
All Product used or sold by Licensee shall consist of a single dose concentrations of Sof and LDV that are the same as the dose concentration for such agent that has been approved by (i) the FDA or (ii) by (y) DCGI and (z) the appropriate regulatory authority having jurisdiction over such Product in the country of sale.
The Study Drug for this Clinical Trial -------------------- for which an application to conduct clinical trial has been filed with DCGI, and seeking for approval.
If DCGI raises objections, Purchaser and DCGI will negotiate in good faith to resolve such objections.
The unique three-layer design dressing Size- 25.6 x 15 cm x varying thicknesses (0.8–1.6cm)); for Negative pressure wound Instillation Therapy system also contains one disposable ruler; 6 sheets of advanced drape; 5 packets of No Sting Barrier Film for skin protection, One dual tube pad for large wounds, it should made up of Grey Polyurethane ester and FDA & CE Certified .It should be DCGI and FDA & CE Certified.
Files Fast-Acting Insulin Aspart injection (ASPARAPID) with DCGI; Strengthens commitment to diabetes management.
The second-largest company in the world for the manufacturing of generic and specialty pharmaceuticals, Mylan N.V received the permission of the Drug Controller General of India (DCGI) for the launch of its generic version of Gilead Sciences Remdesivir drug for the treatment of COVID-19 positive patients in India.
Size- 25.6 x 15 cm x varying thicknesses (0.8– 1.6cm) 553 Vacuum Assisted Wound Closer System Dressing (Instillation Dressing) Two small Polyurethane ester form dressing for VAC instillation therapy with two sheets of drape, one ruler, one trac tubing with 5 or More lumens, 2 packets No Sting Barrier Film for skin protection, it should be DCGI and FDA & CE Certified.
Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards, including manufacturing standards promulgated by the Drug Controller General of Africa, Central America, South America and Caribbean (DCGI) (“Minimum Quality Standards”); and (ii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.
CRO shall notify SPONSOR within seven (7) working days, in receipt of communication letter, in writing of FDA, Health Canada, DCGI and any regulatory body or other government inspection or inquiry concerning this Study conducted for SPONSOR by CRO.