Last Updated on June 3, 2024 by The Health Master
USFDA inspection
In a major win for quality and compliance, Solara Active Pharma Sciences Limited (Solara), a leading manufacturer of Active Pharmaceutical Ingredients (APIs), has announced a successful US Food and Drug Administration inspection (USFDA inspection) inspection of its Visakhapatnam facility.
This news is particularly significant for pharmaceutical companies seeking high-quality Ibuprofen APIs from a reliable and compliant source.
Clean Inspection with Zero Observations
The USFDA inspection, conducted from May 14th to 17th, 2024, resulted in a highly positive outcome for Solara.
The Visakhapatnam facility received an “Acceptable State of Compliance” rating with zero Form 483 inspectional observations.
This signifies that the facility met all USFDA quality and manufacturing standards, a crucial factor for pharmaceutical companies ensuring the safety and efficacy of their drug products.
Solara’s Commitment to Quality
“We are extremely pleased with the successful inspection of our Visakhapatnam API site,” said Poorvank Purohit, Managing Director & CEO of Solara.
“This achievement, with zero observations, highlights our unwavering commitment to the highest quality standards across all our manufacturing facilities.”
Mr. Purohit further emphasized, “We remain agile in adapting to ever-evolving quality and compliance requirements. I am confident that we will continue to foster a strong quality culture within Solara.”
Second Successful USFDA Inspection
This successful inspection marks the second time the USFDA has inspected Solara’s Visakhapatnam facility.
Notably, both inspections have resulted in zero observations, demonstrating Solara’s consistent adherence to regulatory guidelines.
Solara also boasts another USFDA-approved facility in Puducherry, India, further solidifying their position as a reliable supplier of high-quality Ibuprofen APIs.
Visakhapatnam Facility – A Model of Efficiency
Solara’s Visakhapatnam facility is a testament to their commitment to efficient and sustainable manufacturing.
Spread across 40 acres, this greenfield project is dedicated solely to the production of Ibuprofen API.
The facility also boasts backward integration, meaning they manufacture key starting materials for Ibuprofen in-house, ensuring greater control over the entire supply chain.
This translates to a more reliable and potentially more cost-effective source of Ibuprofen APIs for pharmaceutical companies.
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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