MEDICAMEN BIOTECH LTD. announced that Shivalik Rasayan Ltd., which is the parent company of Medicamen, has successfully got USFDA Approval for its state of the art global API manufacturing facility.
Medicamen Biotech is proud to announce that its state-of-the-art manufacturing facility in Bhiwadi, Rajasthan, has achieved European Union Good Manufacturing Practice (EU GMP) certification from the National Organisation for Medicines in Athens, Greece.
We’re excited to announce that our Sterile Oncology Facility is now USFDA approved, enabling us to expand into regulated markets like the US and the Middle East. This milestone reflects our commitment to delivering high-quality oncology treatments globally, supporting patients with advanced, compliant options.
In April 2023, the Oncology Plant located in Haridwar underwent a comprehensive audit by the US Food and Drug Administration (USFDA). This successful audit positions the facility for potential approvals in regulated markets, including the United States and the Middle East.
“This is major milestone for the Company which will trigger USFDA Audit in due course of time” said Medicamen. For the quarter ended March, the company reported a 20 percent year-on-year increase in revenue to Rs 138 crore in FY23 as against the previous year.
Medicamen Biotech के शेयरों में आज 19 जुलाई को 6 फीसदी से अधिक की रैली देखी गई। इस समय यह स्टॉक NSE पर 6.68 फीसदी की बढ़त के साथ 768 रुपये के भाव पर ट्रेड कर रहा है। दरअसल, Medicamen ने US फूड एंड ड्रग एडमिनिस्ट्रेशन (USFDA) के साथ BORTEZOMIB इंजेक्शन के लिए अपना पहला Abbreviated न्यूज ड्रग एप्लिकेशन (ANDA) दायर किया है।
Medicamen Lifesciences, a subsidiary of MEDICAMEN BIOTECH, officially launched operations in 2022. The company specializes in the manufacturing and marketing of pharmaceutical products, with a focus on Anti-hypertensives, Antidiabetics, and Cardiology treatments.
MEDICAMEN has officially initiated domestic oncology marketing, aimed at raising awareness and promoting its range of oncology products. This strategy is designed to enhance the visibility of the company’s offerings in the oncology sector and to engage healthcare professionals and patients effectively.
The company has made significant strides in regulatory compliance by filing Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) and Certificates of Suitability (CEPs) with the European Directorate for the Quality of Medicines (EDQM) for its Active Pharmaceutical Ingredients (APIs).
The Haridwar Formulation Unit II, specializing in Finished Dosage Forms (FDF) for oncology, has officially begun operations. This new facility is set to enhance the production of critical oncology medications, reinforcing the company's commitment to providing high-quality pharmaceutical solutions for cancer treatment.
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