Source Legend
- Human-provided
Entered or confirmed by an authorized person.
- Google
Imported Google information.
- Trial-derived
Calculated or extracted directly from associated trial records.
- AI-inferred
A capability inferred from trial history.
- AI-extracted
An explicit statement extracted from an official source.
- Public registry
Information from a public registry.
- Site record
Information held in the site record.
Source: Site record. GloGen Clinical Research Pvt Ltd
Claim This Site
Are you the site administrator? Claim this site to update information.
Basic Information
Site Overview
GloGen received DCGI approval in December 2024, and since then, we have successfully completed 14 Bioequivalence (BE) studies—including 12 pilot studies and 2 pivotal F2F studies—which were submitted to the USFDA on 13 August 2025 in collaboration with our valued sponsor partners. Our Service Portfolio Bioavailability (BA) & Bioequivalence (BE) Studies Pharmacokinetic (PK) Bioanalysis Complex Generics & Special Population Studies Clinical & Bioanalytical Infrastructure • 100 beds across three independent clinical units o 48-bed clinic o 34-bed clinic o 18-bed clinic • 5-bed ICU with continuous cardiac monitoring Capacity to conduct ~400 Period-I dosings per month Two AB SCIEX LC-MS/MS systems, fully compliant with 21 CFR part 11
Business Status
Business Category
Business Subcategory
Conditions
