SRI KRISHNA PHARMACEUTICALS LTD
Overview
SRI KRISHNA PHARMACEUTICALS LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering ACETAMINOPHEN USP; BUTORPHANOL TARTRATE USP; DIMETHYL FUMARATE USP; DOMPERIDONE PH EUR; ENALAPRIL MALEATE USP PROCESS-II; FOLIC ACID USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SRI KRISHNA PHARMACEUTICALS 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
SRI KRISHNA PHARMACEUTICALS LTD holds 12 active (15 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.
- TOLVAPTANActive2026-04-14
- ENALAPRIL MALEATE USP PROCESS-IIActive2024-07-16
- DIMETHYL FUMARATE USPActive2024-05-29
- GLYBURIDE USPActive2013-04-19
- GLIPIZIDE USPActive2012-05-07
- BUTORPHANOL TARTRATE USPActive2012-01-17
- DOMPERIDONE PH EURActive2010-12-13
- FUROSEMIDE USPActive2009-12-22
- MECLIZINE HYDROCHLORIDE USPActive2009-12-15
- SODIUM PHENYLBUTYRATE USPActive2006-06-30
- FOLIC ACID USPActive2004-08-16
- ACETAMINOPHEN USPActive2002-02-06
- SODIUM PHENYLBUTYRATE GRANULES 100% (KRISOSPB-100)Inactive2010-10-25
- ACETAMINOPHEN GRANULES DC 90%Inactive2004-08-16
- ACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F)Inactive2004-05-27
FDA compliance signals
17 FDA enforcement records linked to this company.
- 4832025-06-27
Complaint Investigation/Follow-Up Findings
- 4832025-06-27
Records not made readily available to FDA
- 4832025-06-27
Rejecting When Specifications Not Met
- 4832025-06-27
Absence of Written Procedures
- 4832025-06-27
Drug products - samples representative, identified properly
- 4832025-06-27
Cleaning / Sanitizing / Maintenance
- 4832025-06-27
Extent of discrepancy, failure investigations
- 4832025-06-27
Investigations of discrepancies, failures
- 4832023-05-19
Procedures not in writing, fully followed
- 4832023-05-19
Buildings not maintained in good state of repair
- 4832023-05-19
Computer control of master formula records
- 4832023-05-19
Master production and control records, procedure
- 4832023-05-19
Cleaning / Sanitizing / Maintenance
- 4832023-05-19
Investigations of discrepancies, failures
- 4832023-05-19
Complaint Handling Procedure
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