Shilpa Medicare

India (registered sites)
Hybrid — also manufactures internal programs
Small Molecule API Oral Solid Dose Sterile Fill-Finish Biologics Peptides & Oligos
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (5) ○ Clinical Trials ○ SEC Filings ✓ Press (5) ○ EMA GMP ✓ MHRA GMP (1) ✓ HC GMP (15)

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
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

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Shilpa Medicare FDA Inspection History

2025-03
2025-03
2024-10
2024-03
2023-03
NAI VAI OAI
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)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Shilpa Medicare FDA 483 Findings 6 observations · 2023-03-10 → 2024-10-30 ?

By subsystem

  • Laboratory Controls 3 (50.0%)
  • Equipment & Facilities 1 (16.7%)
  • Documentation & Records 1 (16.7%)
  • CAPA 1 (16.7%)

By severity

  • 3 — Moderate: 4
  • 2 — Minor: 2
  • Repeat observations: 0

Most severe findings

  • Moderate (3) CAPA 2024-10-30 21 CFR 211.192
    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."

  • Moderate (3) Laboratory Controls 2024-10-30 21 CFR 211.186(b)(9)
    Complete instructions, procedures, specifications et. al.

    "Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures."

  • Moderate (3) Laboratory Controls 2023-03-10 21 CFR 211.160(a)
    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

2022-05
Compliant Non-Compliant
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
Source: MHRA GMDP Database · Retrieved Oct 31, 2026

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Company Signals 5 articles

Company announcements, not verified evidence. They do not change any score.
general 2026-10-22
Shilpa Medicare (BSE:530549) Stock Price - Simply Wall Street
Shilpa Medicare (BSE:530549) Stock Price  Simply Wall Street
regulatory 2026-10-12
Shilpa Medicare Gets European GMP Certification for Unit - Equitypandit
Shilpa Medicare Gets European GMP Certification for Unit  Equitypandit
regulatory 2026-10-12
Shilpa Medicare Receives European GMP Certification For Jadcherla Unit - Sahi
Shilpa Medicare Receives European GMP Certification For Jadcherla Unit  Sahi
regulatory 2026-10-10
Shilpa Medicare's Jadcherla Unit Gets GMP Certification from Austria's AGES for Europe, Global Markets - Medical Dialogues
Shilpa Medicare's Jadcherla Unit Gets GMP Certification from Austria's AGES for Europe, Global Markets  Medical Dialogues
regulatory 2026-10-10
Shilpa Medicare Receives European GMP Certification For Jadcherla Unit Following Austrian Regulatory Inspection - Sahi
Shilpa Medicare Receives European GMP Certification For Jadcherla Unit Following Austrian Regulatory Inspection  Sahi

Frequently Asked Questions About Shilpa Medicare

How many FDA inspections does Shilpa Medicare have on record?
CDMO Signal tracks 5 FDA inspections for Shilpa Medicare, sourced from the FDA inspection database. See the full inspection history above.
Has Shilpa Medicare received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Shilpa Medicare.
Does Shilpa Medicare hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for Shilpa Medicare.
Does Shilpa Medicare have a CDMO Signal Score?
Not yet. Shilpa Medicare is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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