Last Updated on March 30, 2024 by The Health Master
USFDA approval
Lupin Limited has garnered USFDA approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for doxycycline for injection USP, 100 mg/vial (single-dose vial).
This USFDA approval allows Lupin to market a generic equivalent of Vibramycin for injection, 100 mg/vial, originally developed by Pfizer Inc.
Understanding Doxycycline for Injection USP
What is Doxycycline for Injection USP?
Doxycycline for injection USP is a crucial medication indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs.
It is specifically intended for intravenous administration.
Purpose of Doxycycline for Injection USP
The primary purpose of doxycycline for injection USP is to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Its formulation and dosage are tailored to ensure optimal efficacy in combating bacterial infections.
Lupin’s Manufacturing and Distribution
Production Facility
Lupin will manufacture the generic equivalent of Vibramycin for injection at its state-of-the-art facility located in Nagpur, India.
This facility adheres to stringent quality standards and regulatory guidelines to ensure the production of high-quality pharmaceutical products.
Distribution Reach
With its extensive distribution network, Lupin aims to make doxycycline for injection USP accessible to healthcare providers and patients across various regions.
The company’s robust supply chain capabilities enable efficient distribution to over 100 markets worldwide.
About Lupin Limited
Lupin Limited is an innovation-driven pharmaceutical company with a global footprint.
Headquartered in Mumbai, India, Lupin is renowned for its diverse portfolio comprising branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).
The company’s operations span across key markets in the United States, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.
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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