Last Updated on December 22, 2024 by The Health Master
Form 483
Form 483: In the dynamic world of pharmaceuticals, regulatory inspections are routine, ensuring companies adhere to stringent quality standards.
Recently, Alembic Pharma faced scrutiny from the United States Food and Drug Administration (USFDA) regarding its Oncology Formulation Facility.
Let’s delve into the details and understand the implications of the USFDA’s observations.
Understanding the Form 483
1. What is Form 483?
The USFDA issues a Form 483 post-inspection, highlighting potential violations of the FD&C Act and related regulations. Alembic Pharma received such a form with four procedural observations.
2. Procedural Observations Unveiled
A closer look at the four procedural observations made by the USFDA, deciphering their significance and impact on Alembic Pharma’s operations.
Alembic Pharma’s Response and Commitment
3. Swift and Comprehensive Response
Alembic Pharma assures stakeholders of a comprehensive response within the stipulated period.
Understanding the company’s commitment to rectify and maintain the highest quality standards.
4. Upholding Quality Standards
Exploring Alembic Pharma’s dedication to quality, as emphasized in their official statement to the Bombay Stock Exchange (BSE).
Inspection Timeline and Industry Significance
5. Dates of Scrutiny: 28th February to 8th March, 2024
Analyzing the timeline of the USFDA inspection, providing context to the observations made during this period.
6. Industry Impact and Perception
Examining how such USFDA observations can impact not only Alembic Pharma but also the pharmaceutical industry at large.
Addressing concerns and potential repercussions.
Alembic Pharma: A Brief Overview
7. Company Background
Briefly outlining Alembic Pharma’s inception in 1907, its headquarters in Vadodara, Gujarat, and its diverse involvement in manufacturing and marketing pharmaceuticals globally.
8. Varied Offerings: India Formulations, International Generics, and APIs
Understanding Alembic Pharma‘s diverse portfolio, from catering to the Indian market with unique formulations to providing generic medicines globally and manufacturing Active Pharmaceutical Ingredients (APIs).
Quality Assurance
9. Regulatory Approvals
Highlighting Alembic Pharma’s state-of-the-art research and manufacturing facilities, approved by regulatory authorities worldwide, including the stringent USFDA.
10. Vertical Integration Capabilities
Exploring how Alembic’s vertical integration capabilities contribute to its ability to maintain quality across diverse pharmaceutical segments.
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.
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