Last Updated on December 24, 2023 by The Health Master
USFDA Approval
In a groundbreaking development, Strides Pharma Science has proudly announced that its subsidiary, Strides Pharma Global Pte., Singapore, has secured USFDA approval from the United States Food & Drug Administration (USFDA) for its Sodium Sulphate, Potassium Sulphate, and Magnesium Sulphate Oral Solution 17.5g/3.13g/1.6g per 6 ounces.
This milestone positions the product as bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Suprep Bowel Prep Kit Oral Solution 17.5g/3.13g/1.6g per 6 ounces of Braintree Laboratories.
Manufacturing and Marketing after USFDA approval
The approved product holds a significant market size of approximately $143 million, as reported by IQVIA.
Manufactured at the company’s Bengaluru facility, this USFDA approval not only expands Strides Pharma Science’s product portfolio in bowel preparation but also reinforces its position in both prescription and over-the-counter offerings.
This article delves into the specifics of the product, its market implications, and the company’s strategic goals.
Strides Pharma Global Pte. and Regulatory Achievements
As a wholly-owned subsidiary, Strides Pharma Global Pte. plays a pivotal role in the company’s success.
With 260 cumulative ANDA filings, including the recent acquisition from Endo at Chestnut Ridge, Strides Pharma Science has garnered USFDA approval for over 230 ANDAs.
The company now aims to launch around 60 new products over the next three years in the highly competitive US market.
Understanding the Product and Its Purpose
This product is part of a group of medicines prescribed for individuals undergoing a colon cleanse before a colonoscopy.
Packaged in a carton containing two 6-ounce bottles of the liquid and a mixing container, the kit provides a comprehensive solution for effective bowel preparation.
Impact on Healthcare and Future Plans
The USFDA approval of this product holds promising implications for healthcare procedures, particularly in enhancing the preparation process for colonoscopies.
With a commitment to improving patient care, Strides Pharma Science aligns its strategic goals with the expansion of its product portfolio in the US market, contributing significantly to advancements in medical procedures.
Conclusion
In conclusion, Strides Pharma Science’s USFDA approval for its Sodium Sulphate, Potassium Sulphate, and Magnesium Sulphate Oral Solution marks a significant milestone in the pharmaceutical industry.
The product’s bioequivalence and therapeutic equivalence, coupled with the company’s robust portfolio and strategic goals, position Strides Pharma Science as a key player in the field of bowel preparation.
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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What is USFDA approval for drugs?
USFDA approval for drugs is the process by which the United States Food and Drug Administration (USFDA) reviews and evaluates the safety, efficacy, and quality of pharmaceutical products before they can be marketed and sold in the United States.
How does the USFDA approve drugs?
The USFDA approves drugs through a rigorous review process that involves the submission of extensive data and clinical trial results by the pharmaceutical company. The agency assesses the drug’s safety, effectiveness, manufacturing standards, labeling, and potential risks to determine whether it meets the necessary criteria for approval.
Why is USFDA approval important for drugs?
USFDA approval is crucial as it ensures that drugs meet high standards of safety, efficacy, and quality before they reach consumers. This rigorous approval process helps protect public health by minimizing the risks associated with using medications and ensuring their effectiveness in treating specific medical conditions.
How long does the USFDA approval process take?
The USFDA approval process duration can vary depending on several factors, such as the complexity of the drug, available data, and the review workload. On average, it takes around 10 months to over a year for a new drug to go through the entire approval process, including the different stages of review and evaluation.
Are all drugs required to have USFDA approval?
Yes, in the United States, all drugs must undergo USFDA approval before they can be legally marketed and sold. This requirement applies to both brand-name drugs and generic drugs. Without USFDA approval, it is illegal to distribute or promote medications for commercial use.
How can I verify if a drug has USFDA approval?
To verify if a drug has USFDA approval, you can visit the USFDA website or use the agency’s online resources, such as the Drug Approval Reports or the Electronic Orange Book. These tools provide information about the approved drugs, including their active ingredients, indications, and the companies responsible for their manufacturing and marketing.
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