Sun Pharmaceutical Industries Limited
This drug manufacturing facility is registered with the FDA by Sun Pharmaceutical Industries Limited. ProPublica was able to identify at least 212 generic drugs that have been manufactured at this facility.
Facility Under Import Ban
This facility was on the FDA's import ban list last time we checked (November 2025), relating to failures in good manufacturing practices.
The following drug(s) were exempted from the ban at that time: Vecuronium Injection, Divalproex Delayed Release Tables, Doxorubicin HCl Liposomal Injection
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.
12
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.
8
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.
- Jun 13, 2025Jun 13, 2025Inspection 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.8 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.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.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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 16, 2023Oct 16, 2023Warning 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. - Dec 7, 2022Dec 7, 2022Import Ban
The FDA banned the import of medications from this facility.
An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country. - May 9, 2022May 9, 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.10 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Aseptic Processing AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 13, 2019Dec 13, 2019Inspection 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.8 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Environmental Monitoring SystemAseptic processing areas are deficient regarding the system for monitoring environmental conditions.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.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jun 11, 2019Jun 11, 2019Inspection With Issues
The FDA determined this facility was in an acceptable state, though an inspector documented issues.
The FDA ultimately considered the facility to be in an acceptable state of compliance, which is the best possible outcome for an inspection. It’s impossible to know exactly what happened in this case, but an inspector filed a 483 report documenting issues, possibly as a part of a concurrent inspection that we don’t have an outcome for.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Dec 6, 2018Dec 6, 2018Inspection
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. - Aug 31, 2018Aug 31, 2018Inspection
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. - Feb 23, 2018Feb 23, 2018Inspection 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.3 citations
Aseptic Processing AreaSeparate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.Written procedures fail to includeWritten procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for removal or obliteration of previous batch identification.Procedures To Be in WritingWritten procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 1, 2016Dec 1, 2016Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Sep 16, 2014Sep 16, 2014Inspection 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.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Sep 28, 2012Sep 28, 2012Inspection 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. - Jun 13, 2012Jun 13, 2012Inspection 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. - Apr 7, 2011Apr 7, 2011Inspection
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.
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.
CompanySun Pharmaceutical Industries
Dosage
10mg
White to off-white round tablet, extended release marked with 956
NDC: 47335-956-X
CompanyBryant Ranch Prepack
Dosage
10mg
White to off-white round tablet, extended release marked with 956
NDC: 72162-1449-9
CompanyNorthwind Pharmaceuticals
Dosage
10mg
White to off-white round tablet, extended release marked with 956
NDC: 51655-432-52
CompanyBryant Ranch Prepack
Dosage
10mg
White to off-white round tablet, extended release marked with 956
NDC: 71335-2146-X
CompanySun Pharmaceutical Industries
Dosage
137mcg
Spray, metered in a bottle, spray (200)
NDC: 47335-779-91
CompanySun Pharmaceutical Industries
Dosage
0.5mg/mL
Solution/ drops in a bottle, plastic (6mL)
NDC: 47335-938-90
CompanySun Pharmaceutical Industries
Dosage
Azithromycin Monohydrate
500mg/5mL
Injection, powder, lyophilized, for solution in a vial (5mL)
NDC: 62756-512-X
CompanyProficient Rx Lp
Dosage
150mg
White to off-white round tablet, film coated, extended release marked with 737
NDC: 63187-052-X
CompanySun Pharmaceutical Industries
Dosage
150mg
White to off-white round tablet, film coated, extended release marked with 737
NDC: 47335-737-X
CompanyProficient Rx Lp
Dosage
100mg
White to off-white round tablet, film coated, extended release marked with 736
NDC: 63187-176-X
CompanyProficient Rx Lp
Dosage
200mg
White to off-white round tablet, film coated, extended release marked with 738
NDC: 63187-178-X
CompanySun Pharmaceutical Industries
Dosage
100mg
White to off-white round tablet, film coated, extended release marked with 736
NDC: 47335-736-X
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