
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.
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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.
Disease areas (46)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Dyslipidemias | 8 |
| Hypoalphalipoproteinemias | 7 |
| Lecithin Cholesterol Acyltransferase Deficiency | 7 |
| Rosacea | 6 |
| Arthritis, Rheumatoid | 5 |
Showing 5 of 46 disease areas.
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
| 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 |
Showing 10 of 26 years.
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.
| 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 |
Showing 5 of 15 active programs.
Approved assets (77)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Levofloxacin | 2 |
| OMEZ 40 | 1 |
| OMEZ 80 | 1 |
| Ketorolac Tromethamine | 1 |
| PANITUMUMAB | 1 |
Showing 5 of 77 approved assets.
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.
| Enrollment | Timeline |
|---|---|
| 88% hit target (n=8) | 14% on time (n=7) |
Journals published in (17)
Shown in this order: most published in first.
| 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 |
Showing 5 of 17 journals.
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 patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 190 | 12 | 2025-10-07 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 59 |
FDA recalls (1)
| 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)
| Refused import lines | Latest refusal |
|---|---|
| 125 | 2026-08-14 |
Manufacturing and distribution sites (22)
Shown in this order: severity rank then name.
| 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 |
Showing 5 of 22 sites.
Organization relationships (25)
Shown in this order: most evidence first.
| 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 |
Showing 5 of 25 relationships.
Latest dated events (794)
Shown in this order: newest first.
| 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) |
Showing 5 of 794 events.
Biomarker capability evidence (136)
Shown in this order: tier desc, then gene symbol.
| 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 |
Showing 5 of 136 evidence rows.
Biomarkers this organization publishes on (13)
Shown in this order: most publications first.
Showing 5 of 13 biomarkers.
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.