SHILPA MEDICARE LTD
Overview
SHILPA MEDICARE LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering SUNITINIB.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SHILPA MEDICARE LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
SHILPA MEDICARE LTD holds 1 active (2 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- SUNITINIBActive2021-04-21
- ANASTROZOLEInactive2009-09-23
FDA compliance signals
18 FDA enforcement records linked to this company.
- recall — Class II2026-08-26
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- recall — Class II2026-08-26
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- 4832024-10-30
Signature and checking of records -- 2 persons
- 4832024-10-30
Complete instructions, procedures, specifications et. al.
- 4832024-10-30
Calibration/Inspection/Checking not done
- 4832024-10-30
Written record of investigation incomplete
- 4832023-03-10
Following/documenting laboratory controls
- 4832023-03-10
Lab controls established, including changes
- recall — Class II2020-12-16
CGMP Deviations
- recall — Class II2020-12-16
CGMP Deviations
- recall — Class II2020-12-16
CGMP Deviations
- recall — Class II2020-12-16
CGMP Deviations
- recall — Class II2020-12-16
CGMP Deviations
- recall — Class II2020-12-16
CGMP Deviations
- warning_letter2020-10-09
FDA Warning Letter (drug product)
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