Glenmark Pharmaceuticals Limited
⚠️ Moderate Risk
FEI: 3004672766 • Colvale, Goa • INDIA
FEI Number
3004672766
Location
Colvale, Goa
Country
INDIAAddress
Plot No S - 7, Colvale Industrial Estate, Colvale, Goa, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
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 |
|---|---|---|---|
| 2/8/2016 | 65JDA27NORGESTIMATE (PROGESTIN) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/4/2015 | 62ODA47MOEXIPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3847FDF4APIGMP | Philadelphia District Office (PHI-DO) |
| 2/4/2015 | 62ODA47MOEXIPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 3847FDF4APIGMP | Philadelphia District Office (PHI-DO) |
| 12/10/2007 | 65JDB24NORETHINDRONE (PROGESTIN) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glenmark Pharmaceuticals Limited's FDA import refusal history?
Glenmark Pharmaceuticals Limited (FEI: 3004672766) has 4 FDA import refusal record(s) in our database, spanning from 12/10/2007 to 2/8/2016.
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. Glenmark Pharmaceuticals Limited's FEI number is 3004672766.
What types of violations has Glenmark Pharmaceuticals Limited received?
Glenmark Pharmaceuticals 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 Glenmark Pharmaceuticals Limited come from?
All FDA import refusal data for Glenmark Pharmaceuticals 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.