Organization (Industry)
BIOCON LIMITED
ClinicalTrials.gov lists BIOCON LIMITED as lead sponsor of 14 trials, counting the companies grouped under it. BIOCON LIMITED itself has 5 active development programs and 2 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers BIOCON LIMITED and 4 companies grouped under it: 14 lead-sponsored trials (13 its own, 1 in the grouped companies) and 13 legal-entity registrations (5 its own, 8 in the grouped companies).
Companies grouped under this page (4)
Shown in this order: most lead trials first.
| Company | Lead trials | Legal entities |
|---|---|---|
| BIOCON BIOLOGICS LIMITED | 1 | 1 |
| BIOCON SDN. BHD. | 0 | 1 |
| SYNGENE INTERNATIONAL LIMITED | 0 | 4 |
| SYNGENE SCIENTIFIC SOLUTIONS LIMITED | 0 | 2 |
Disease areas (12)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Diabetes Mellitus | 3 |
| COVID-19 | 2 |
| Diabetes Mellitus, Type 1 | 2 |
| Graft vs Host Disease | 2 |
| Asthma | 1 |
Showing 5 of 12 disease areas.
Trials by start year as sponsor or collaborator (7)
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 |
|---|---|
| 2022 | 2 |
| 2020 | 2 |
| 2019 | 7 |
| 2017 | 1 |
| 2014 | 1 |
| 2012 | 1 |
| 2010 | 1 |
Recruitment duration, a model prediction: none of the 13 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (5)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Itolizumab | COVID-19 | Phase 3 | 1 |
| Itolizumab | Graft vs Host Disease | Phase 1/2 | 1 |
| Itolizumab [Bmab 600] | Lupus Erythematosus, Systemic | Phase 1 | 1 |
| Itolizumab [Bmab 600] | Lupus Nephritis | Phase 1 | 1 |
| Itolizumab | Asthma | Phase 1 | 1 |
Approved assets (2)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Insulin Aspart | 1 |
| HUMAN INSULIN (BIOSYNTHETIC) | 4 |
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 |
|---|---|
| 40% hit target (n=10) | 33% on time (n=9) |
Journals published in (5)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Advances in therapy | 1 |
| Clinical pharmacology in drug development | 1 |
| Diabetes, obesity & metabolism | 1 |
| Expert opinion on pharmacotherapy | 1 |
| Haematologica | 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 patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 126 | 13 | 2025-12-30 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 16 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 5 | 2025-06-30 |
Manufacturing and distribution sites (5)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Biocon Limited | Bengaluru, IN | EMA, FDA, Health Canada | |
| Biocon Limited | Bengaluru, IN | EMA, FDA | |
| Biocon Limited | Anakapalli, IN | FDA | |
| BIOCON PHARMA LIMITED | Bengaluru, IN | EMA, FDA, Health Canada | |
| Biocon Limited | Sangareddy, IN | FDA, Health Canada |
Organization relationships (2)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Iqvia Holdings Inc. | Uses vendor | 1 |
| Profil Institute for Metabolic Research | Co sponsors trial with | 1 |
Latest dated events (207)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-03-26 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-30 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-09-12 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-09-03 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-07-08 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 207 events.
Biomarker capability evidence (28)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| LTA | Trial sponsor | Named in trial inclusion criteria |
| CD4 | Trial sponsor | Named in trial exclusion criteria |
| IL17A | Trial sponsor | Exploratory endpoint in a trial |
| IL17A | Trial sponsor | Named in trial exclusion criteria |
| NUP214 | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 28 evidence rows.
On Scientist.com
BIOCON LIMITED is listed as a research supplier in the Scientist.com network.
Service areas
Syngene (A Biocon Company) was established in 1994 and is India’s leading CRO with multi-disciplinary skills in integrated drug discovery and development. Our capabilities include medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing and formulation development for both small and large molecules. These services are offered on a strong platform of confidentiality and intellectual property protection. Our research facilities are certified with ISO 9001:2008, ISO 14001:2004, OHSAS 18001:2007. Our animal facilities are GLP certified...
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*Discovery Chemistry Services*-
* Medicinal Chemistry * Library Generation * Scaffold & Building Blocks Synthesis*Process Development Services*-
* New Process Development * Optimization of existing processes * Scale up and supplies up to 10s of Kg levels*Custom Synthesis Services*-
* Production scale up for clinical supplies * Commercial manufacturing of NCE and AIs up to 100s of Kg levels*Analytical Services*-
* Impurity Identification, Reference Standard Qualification/Characterization * Method Development, Optimization & Validation * Intermediate & API Stability Studies * Risk Analysis * Polymorph Studies*Polymer Chemistry & Catalysis Services*-
* Lab to Kg scale development of polymers with focus on bio-polymers and specialty polymers * Formulation Development * Development of Solid Orals h2. Biology*Molecular Biology*
* Recombinant DNA Technology * Strain Engineering * Gene Expression * Library Construction & Screening*Cell Line Development*
* Cell culture * cell line characterization * Research cell banking*Protein Sciences*
* Protein Purification * Protein Characterization * Crystallography Screening*Assay Biology*
* Assay Development and Validation * Biochemical Assays and Cell Based Assays*Antibody Production*
* Polyclonal * Hybridoma * Recombinant Monoclonal Antibodies*Microbiology*
* Antimicrobial Susceptibility * Mutant Generation*ADMET & DMPK*
* Aqueous Solubility * Permeability * CYP450 Inhibition * Metabolic Stability * Plasma Protein Binding * Cytotoxicity * Pharmacokinetics*in vivo Pharmacology*
* Oncology * Metabolic Disorders * Inflammation * Pain Models * Auto-immune Disorders * Osteoarthritis h2. Toxicology * Discovery Toxicology * Battery of Genetic Toxicology Studies * Acute, Sub-Chronic and Chronic Toxicology Studies * Developmental and Reproductive Toxicology Studies h2. Biologics * Process Development and Optimization * Scale-up and technology transfer * Pilot Scale Production (cGMP) * Formulation Development and Lyophilization * Stability Studies- Professional associations
- AAPS, ACS, RSC
- Website
- www.syngeneintl.com
Not on this page
Checked, with nothing recorded for this organization: related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda recalls, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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