Shilpa Medicare
Quick Facts: Shilpa Medicare
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- India (registered sites)
- Website
- https://vbshilpa.com/
- Modalities
- Small Molecule API, Oral Solid Dose, Sterile Fill-Finish, Biologics, Peptides & Oligos
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Shilpa Medicare
Shilpa Medicare makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Oral Solid Dose, Sterile Fill-Finish, Biologics, Peptides & Oligos. 3 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://vbshilpa.com/
Signal Score
Shilpa Medicare FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-03-14 |
Shilpa Pharma Lifesciences Limited
Chicksugur, Raichur
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-03-07 |
Shilpa Pharma Lifesciences Limited
Deosugur
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-10-30 |
Shilpa Medicare Limited
Dabaspet, Bengaluru
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-03-01 |
Shilpa Medicare Limited
Hyderbad
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2023-03-10 |
Shilpa Medicare Limited
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Shilpa Medicare FDA 483 Findings 6 observations · 2023-03-10 → 2024-10-30 ?
By subsystem
By severity
- 3 — Moderate: 4
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Written record of investigation incomplete
"Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up."
-
Complete instructions, procedures, specifications et. al.
"Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures."
-
Lab controls established, including changes
"The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit."
Shilpa Medicare MHRA GMP Compliance 1 certificates
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 31637 Insp GMP 31637/23565175-0001[H] | SHILPA MEDICARE LIMITED | IN-562 111 | 2022-05-18 | COMPLIANT |