Last Updated on October 11, 2024 by The Health Master
Guaifenesin ER Tablets
Marksans Pharma, a prominent pharmaceutical company, has achieved a significant milestone by securing final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin ER Tablets, available in both 600 mg and 1200 mg variants and sold over-the-counter (OTC).
USFDA Approval of Guaifenesin ER Tablets Paves the Way:
The recent approval from the USFDA marks a pivotal moment for Marksans Pharma, solidifying their position as a key player in the pharmaceutical industry.
This approval applies to their Guaifenesin Extended-Release (ER) Tablets, which come in 600 mg and 1200 mg options and fall under the OTC category.
This achievement showcases the company’s commitment to delivering high-quality pharmaceutical solutions to the market.
Matching Bioequivalence of Guaifenesin ER Tablets
The Guaifenesin ER Tablets in 600 mg and 1200 mg (OTC) variants have been deemed bioequivalent to the reference listed drug (RLD) known as Mucinex Extended-Release Tablets.
The reference drug, available in the same 600 mg and 1200 mg strengths, is marketed by RB Health (US) LLC.
This equivalence is a testament to the rigorous research and development efforts undertaken by Marksans Pharma to ensure the effectiveness and safety of their product.
Aiding Respiratory Wellness:
Guaifenesin ER tablets serve a crucial medical purpose: they effectively assist in loosening phlegm and thinning bronchial secretions.
By facilitating the removal of troublesome mucus and enhancing the productivity of coughs, these tablets play a vital role in promoting healthier bronchial passageways.
This mechanism can help to a great extent to relieve the discomfort brought on by accumulation of too much mucus and encourage improved respiratory function.
Immediate Product Launch Expected:
With the USFDA’s green light, Marksans Pharma is gearing up for an immediate launch of their Guaifenesin ER Tablets.
This quick response demonstrates the company’s readiness to make this much-needed pharmaceutical product available to consumers without delay.
The availability of these tablets could bring relief to individuals suffering from respiratory issues, further solidifying Marksans Pharma’s commitment to enhancing public health.
Conclusion:
Marksans Pharma’s recent USFDA approval for their Guaifenesin ER Tablets, available in 600 mg and 1200 mg strengths and offered over-the-counter, signifies a significant advancement in the field of pharmaceuticals.
The bioequivalence to the reference listed drug and the tablets’ effectiveness in promoting respiratory wellness make them a valuable addition to the market.
As the company prepares for an imminent product launch, it reinforces their dedication to addressing health challenges and improving the quality of life for consumers.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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