levofloxacin hemihydrate Injection 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Taiwan
GMP approvals
PICS
Manufacturer #20569
The company was founded in the 1970s to deliver high-quality generic medications to patients across the globe. The company has state-of-the-art research and development unit, quality control and quality assurance department and PIC/S GMP certified manufacturing facility focusing on large infusion parenteral (LVP), small injection parenteral (SVP), oral medicine, and medical equipment production. The company enjoys a rich manufacturing experience of over 40 years and has a robust product portfolio spread over major product areas encompassing Antibiotics, analgesics, hormones, vitamins, CNS, etc. Recently, the company complies with the newest material of eco-friendly and nontoxic Non-PVC to produce infusion soft bags and introduces aseptic process technology for vitamin production.

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Levofloxacin hemihydrate

Levofloxacin hemihydrate is a fluoroquinolone antibiotic medication, of the third generation of this family of antibiotics and a part of the Levofloxacin family of antibiotics. It is used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, H. pylori (in combination with other medications), urinary tract infections, chronic prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis, meningitis, or pelvic inflammatory disease. Levofloxacin hemihydrate is sold under the brand names Levaquin, Aleflox, Diolof among others. Daiichi Pharmaceutical Company initially developed it for the treatment of bacterial sinusitis through a process for selectively producing hydrate crystals and approved for medical use in the The United States in 1996.

Dosage and administration

The ingredient version is supplied as a yellowish-white crystalline powder. Levofloxacin hemihydrate is sold as tablets in 500mg strength and taken orally. In the treatment of Levaquin disease, the recommended initial adult dose is 250mg,500mg, or 750mg administered orally every 24 hours.

Price of Levofloxacin hemihydrate

In the international market, the consumer has to pay a retail price of $112.74 for a supply of 10 tablets of 500mg strength. in the Chinese API market, depending on the grade, purity, and quality, a kilogram can be bought for a price between USD 35 and USD 50. This price is cheaper is between USD 150 and USD 200 for the ingredient being exported out of India.

How does it work?

Levofloxacin is a broad-spectrum antibiotic, which has been found to have potent actions against both Gram-positive and Gram-negative bacteria. Like all quinolones, it functions by inhibiting the DNA gyrase and topoisomerase IV, two bacterial types II topoisomerases. Topoisomerase IV is necessary to separate DNA that has been replicated (doubled) prior to bacterial cell division. With DNA separation being inhibited, and the process halted, the bacterium cannot divide further. DNA gyrase, on the other hand, is responsible for supercoiling the DNA, so that it will fit in the newly formed cells. Both mechanisms amount to killing the bacterium thus fulfilling its primary role of being a bactericide.

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