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Organization (Industry)

DR. REDDY'S LABORATORIES LIMITED

ClinicalTrials.gov lists DR. REDDY'S LABORATORIES LIMITED as lead sponsor of 226 trials. It has 15 active development programs and 77 approved assets.

IN Industry Manufacturer
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37 0 1998 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 2 registered with a 2026 start date. The dashed outline is the pace from the 2 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.6 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo The Hindu Business Line, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers DR. REDDY'S LABORATORIES LIMITED: 226 lead-sponsored trials and 10 legal-entity registrations. Part of DR REDDYS LABORATORIES LTD.

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Disease areas (46)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Dyslipidemias 8
Hypoalphalipoproteinemias 7
Lecithin Cholesterol Acyltransferase Deficiency 7
Rosacea 6
Arthritis, Rheumatoid 5

Trials by start year as sponsor or collaborator (26)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 2
2024 1
2023 1
2022 4
2021 2
2020 3
2019 1
2018 3
2017 8
2016 3

Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (15)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
Experimental: Arm A: DRL_RI Arthritis, Rheumatoid Phase 3 1
DRL_RI Lymphoma Phase 3 1
DRL_RI Lymphoma, Follicular Phase 3 1
DRL_RI Lymphoma, Non-Hodgkin Phase 3 1
Arm B: Rituxan®/Mabthera® Arthritis, Rheumatoid Phase 3 1

Approved assets (77)

Shown in this order: max phase first.

Approved assets
Drug Trials
Levofloxacin 2
OMEZ 40 1
OMEZ 80 1
Ketorolac Tromethamine 1
PANITUMUMAB 1

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
88% hit target (n=8) 14% on time (n=7)

Journals published in (17)

Shown in this order: most published in first.

Journals published in
Journal Publications
The journal of headache and pain 4
BJOG : an international journal of obstetrics and gynaecology 1
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 1
Clinical drug investigation 1
Clinical medicine insights. Gastroenterology 1

US granted patents (1)

Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.

US granted patents
US patents granted Granted in the last 5 years Most recent grant
190 12 2025-10-07

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
NAI 59

FDA recalls (1)

FDA recalls
Product Classification Initiated
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 Class II 2023-06-21

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
125 2026-08-14

Manufacturing and distribution sites (22)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
DR. REDDY'S LABORATORIES LIMITED Medchal-Malkajgiri, IN FDA
DR REDDY'S LABORATORIES LIMITED Srikakulam, IN EMA, FDA, Health Canada
DR. REDDY'S LABORATORIES LIMITED Nalgonda, IN FDA
DR. REDDY'S LABORATORIES LIMITED Sangareddy, IN FDA, Health Canada
DR.REDDY'S LABORATORIES LIMITED Medchal-Malkajgiri, IN EMA, FDA, Health Canada

Organization relationships (25)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Parexel Uses vendor 2
Syneos Health (United States) Uses vendor 2
Lupin Pharmaceuticals (United States) Co sponsors trial with 1
Cipla (India) Co sponsors trial with 1
Merck & Co., Inc., Rahway, NJ, USA (United States) Co sponsors trial with 1

Latest dated events (794)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-08-19 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-08-14 FDA import refusal FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2026-08-13 FDA import refusal FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)
2026-08-10 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-06-01 FDA import refusal FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment)

Biomarker capability evidence (136)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ALB Trial collaborator Named in trial inclusion criteria
ALB Trial collaborator Primary endpoint in a Phase 3 trial
BCL2A1 Trial collaborator Primary endpoint in a Phase 3 trial
CEACAM5 Trial sponsor Named in trial inclusion criteria
CEACAM5 Trial sponsor Named in trial inclusion criteria

Biomarkers this organization publishes on (13)

Shown in this order: most publications first.

Biomarkers this organization publishes on
Biomarker Publications
MT-CO2 3
GPT 2
KRT20 2
MT-CO1 2
CD19 1

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, and clia clinical laboratory certificates.