Last Updated on January 4, 2025 by The Health Master
Aarti Drugs
Aarti Drugs Limited has recently received its Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) following an inspection at its API manufacturing facility in Tarapur, Maharashtra.
The USFDA classified the inspection as “Voluntary Action Indicated” (VAI), signifying that while some objectionable conditions or practices were observed, the agency does not intend to take any immediate regulatory action.
What Does “Voluntary Action Indicated (VAI)” Mean?
VAI indicates that the USFDA found the facility to be in a minimally acceptable state of compliance with current good manufacturing practices (cGMP).
While the company is not facing immediate regulatory consequences, it is expected to address the identified issues voluntarily.
Key Takeaways from the USFDA Inspection:
- Minimal Compliance: The facility was deemed to have met the minimum requirements for cGMP, although minor deficiencies were noted.
- No Immediate Action: The USFDA will not be taking any immediate administrative or regulatory action against Aarti Drugs based on this inspection.
- Continued Export to the US Market: Aarti Drugs can continue to export key products to the US market, including Ciprofloxacin HCl API, Zolpidem Tartrate API, Raloxifene HCl API, Celecoxib API, and Niacin API.
Background on Aarti Drugs:
- Established in 1984: Aarti Drugs is a leading manufacturer of Active Pharmaceutical Ingredients (APIs), Pharma Intermediates, and Specialty Chemicals.
- Part of the Aarti Group: The company is a part of the $900 Million Aarti Group of Industries, a diversified conglomerate with a strong focus on research and development.
- Product Portfolio: Aarti Drugs produces a wide range of products, including key APIs like Ciprofloxacin Hydrochloride, Metronidazole, and Metformin HCL, as well as specialty chemicals such as Benzene Sulphonyl Chloride and Methyl Nicotinate.
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What is an EIR?
An EIR is a detailed report issued by the USFDA following an inspection of a pharmaceutical manufacturing facility. It outlines the findings of the audit and any observations made by the inspectors.
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What does “Voluntary Action Indicated” imply?
VAI is a classification used by the USFDA to indicate that while some deficiencies were found during an inspection, the agency does not consider them serious enough to warrant immediate regulatory action.
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Can Aarti Drugs continue to export to the US market?
Yes, despite the VAI classification, Aarti Drugs can continue to export its products to the US market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This article is for informational purposes only and should not be considered investment advice. The information provided in this article is based on publicly available information and may not be complete or accurate.
Note: This article is for informational purposes only and should not be considered financial or investment advice.
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