Glenmark Pharmaceuticals Limited
This drug manufacturing facility is registered with the FDA by Glenmark Pharmaceuticals Inc., Usa. ProPublica was able to identify at least 490 generic drugs that have been manufactured at this facility.
Facility Inspection History
The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.
Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns.
6
Known Inspections
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
5
Inspections Found Issues
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- Nov 22, 2022Nov 22, 2022Warning Letter
The FDA issued a warning letter laying out significant issues.
The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public. - May 20, 2022May 20, 2022Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.5 citations
Equipment Design, Size and LocationEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.Absence of Written ProceduresThere are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.Scientifically sound laboratory controlsLaboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Sep 27, 2019Sep 27, 2019
An inspector documented issues at the facility.
We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Mar 15, 2019Mar 15, 2019Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.5 citations
Approve or reject procedures or specsThe quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.Cleaning / Sanitizing / MaintenanceEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.Scientifically sound laboratory controlsLaboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - May 30, 2014May 30, 2014Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Jul 19, 2013Jul 19, 2013Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.4 citations
Written Procedures Not FollowedWritten procedures are not followed for the receipt and identification of drug product containers and closures.Procedures for non-sterile drug productsProcedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.Investigations of discrepancies, failuresThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Oct 12, 2011Oct 12, 2011Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Nov 20, 2009Nov 20, 2009Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Drugs Manufactured Here
Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.
CompanyAmerican Health Packaging
Dosage
333mg
To off-white round tablet, delayed release marked with 435
NDC: 60687-121-X
CompanyGlenmark Pharmaceuticals Inc., Usa
Dosage
333mg
To off-white round tablet, delayed release marked with 435
NDC: 68462-435-X
CompanyMajor Pharmaceuticals
Dosage
333mg
To off-white round tablet, delayed release marked with 435
NDC: 0904-7213-04
CompanyGlenmark Pharmaceuticals Inc., Usa
Dosage
5%
Ointment in a tube (15g)
NDC: 68462-746-X
CompanyGlenmark Pharmaceuticals Inc., Usa
Dosage
Adapalene
0.1%
Benzoyl Peroxide
2.5%
Gel in a tube (45g)
NDC: 68462-301-X
CompanyA-s Medication Solutions
Dosage
Atomoxetine Hydrochloride
100mg
Reddish brown capsule marked with 271 100
NDC: 50090-7463-0
CompanyA-s Medication Solutions
Dosage
Atomoxetine Hydrochloride
25mg
Blue, white capsule marked with 267 25
NDC: 50090-7342-0
CompanyA-s Medication Solutions
Dosage
Atomoxetine Hydrochloride
60mg
Blue, yellow capsule marked with 269 60
NDC: 50090-7397-0
CompanyNorthstar Rx
Dosage
Atomoxetine Hydrochloride
60mg
Blue, yellow capsule marked with 269 60
NDC: 16714-759-01
CompanyGlenmark Pharmaceuticals Inc., Usa
Dosage
Atomoxetine Hydrochloride
25mg
Blue, white capsule marked with 267 25
NDC: 68462-267-X
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