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Intas Pharmaceuticals Limited

India See location details
Last FDA Action: Jul 28, 2023
Recent Compliance Action Read more

This drug manufacturing facility is registered with the FDA by Intas Pharmaceuticals Limited. ProPublica was able to identify at least 398 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: 62 I [] [] 32, Azacitidine Injection, Methotrexate tablet, Clonazepam tablet, Methotrexate Injection, Cisplatin Injection, Atropine Injection, Carboplatin 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. Read more
7 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.

  • Jul 28, 2023
    Jul 28, 2023
    Warning 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.
    View Warning Letter
  • Jun 1, 2023
    Jun 1, 2023
    Import 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.
  • Dec 2, 2022
    Dec 2, 2022
    Inspection 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 Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    11 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Environmental Monitoring System
    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
    Computer control of master formula records
    Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Feb 28, 2020
    Feb 28, 2020
    Inspection 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 Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • May 28, 2019
    May 28, 2019
    Inspection 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 Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Oct 19, 2016
    Oct 19, 2016
    Inspection 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
    Training , Education , Experience overall
    Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    Validation lacking for sterile drug products
    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 19, 2014
    Dec 19, 2014
    Inspection

    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.
  • Jun 27, 2013
    Jun 27, 2013
    Inspection

    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.
  • Oct 21, 2011
    Oct 21, 2011
    Inspection 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.

Allopurinol

CompanyAphena Pharma Solutions - Tennessee
Dosage
100mg
White to off white round tablet marked with AW
NDC: 71610-678-X

Allopurinol

CompanySt. Mary's Medical Park Pharmacy
Dosage
300mg
White to off white round tablet marked with AX
NDC: 60760-139-90

Allopurinol

CompanyProficient Rx Lp
Dosage
300mg
White to off white round tablet marked with AX
NDC: 71205-049-X

Allopurinol

CompanySt. Mary's Medical Park Pharmacy
Dosage
100mg
White to off white round tablet marked with AW
NDC: 60760-134-90

Allopurinol

CompanyNucare Pharmaceuticals
Dosage
100mg
White to off white round tablet marked with AW
NDC: 66267-665-X

Allopurinol

CompanyPreferred Pharmaceuticals
Dosage
100mg
White to off white round tablet marked with AW
NDC: 68788-7383-X

Allopurinol

CompanyA-s Medication Solutions
Dosage
100mg
White to off white round tablet marked with AW
NDC: 50090-5168-X

Allopurinol

CompanyNorthwind Pharmaceuticals
Dosage
100mg
White to off white round tablet marked with AW
NDC: 51655-523-52

Allopurinol

CompanyAdvanced Rx Pharmacy Of Tennessee
Dosage
300mg
White to off-white round tablet marked with AX
NDC: 80425-0206-X

Allopurinol

CompanyAccord Healthcare
Dosage
100mg
White to off white round tablet marked with AW
NDC: 16729-134-X

Allopurinol

CompanyAccord Healthcare
Dosage
300mg
White to off white round tablet marked with AX
NDC: 16729-135-X

Allopurinol

CompanyBryant Ranch Prepack
Dosage
300mg
White to off white round tablet marked with AX
NDC: 71335-0112-X

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means 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. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means 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. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].