Piramal Pharma Limited
⚠️ High Risk
FEI: 3005259207 • Pithampur, Madhya Pradesh • INDIA
FEI Number
3005259207
Location
Pithampur, Madhya Pradesh
Country
INDIAAddress
Plot 67 - 70, Sector Ii; District Dhar, Pithampur, Madhya Pradesh, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2025 | 61ECK08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2021 | 64DBL99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2021 | 65KCY10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2020 | 64DAL01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | Division of Southeast Imports (DSEI) | |
| 1/4/2017 | 60XCY26LEVOBUNOLOL HYDROCHLORIDE (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/14/2011 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/14/2011 | 62GDK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Piramal Pharma Limited's FDA import refusal history?
Piramal Pharma Limited (FEI: 3005259207) has 7 FDA import refusal record(s) in our database, spanning from 7/14/2011 to 11/1/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Piramal Pharma Limited's FEI number is 3005259207.
What types of violations has Piramal Pharma Limited received?
Piramal Pharma Limited has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Piramal Pharma Limited come from?
All FDA import refusal data for Piramal Pharma Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.