PIRAMAL CRITICAL CARE INC
Overview
PIRAMAL CRITICAL CARE INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering DESFLURANE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances PIRAMAL CRITICAL CARE INC 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
PIRAMAL CRITICAL CARE INC holds 1 active (1 total) FDA Type II Drug Master File — 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.
- DESFLURANE USPActive2007-12-06
FDA compliance signals
14 FDA enforcement records linked to this company.
- 4832023-09-27
Cleaning/maintenance records not kept
- 4832023-09-27
Absence of Written Procedures
- recall — Class II2021-10-27
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
- recall — Class II2019-08-07
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
- 4832014-10-31
Written record of investigation incomplete
- 4832014-10-31
Actual vs. theoretical yields not determined
- 4832014-10-31
Scientifically sound laboratory controls
- 4832014-10-31
Procedures not in writing, fully followed
- 4832014-10-31
input/output verification
- 4832014-10-31
Investigations of discrepancies, failures
- recall — Class II2014-05-07
Failed pH Specifications: product was too acidic.
- 4832013-07-26
Investigations of discrepancies, failures
- 4832013-07-26
Procedures for non-sterile drug products
- 4832013-07-26
Scientifically sound laboratory controls
Is this PIRAMAL CRITICAL CARE INC? Get in front of buyers actively sourcing.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Related companies
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.