Wockhardt Ltd will be launching Azithromycin tablets in the US. The company has received approval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 250mg, 500mg and 600mg azithromycin, which is used for treating various kinds of infections. Azithromycin is the generic name for the brand Zithromax, sold in the US by Pfizer."Wockhardt is only one of the four companies to have received this approval," said Wockhardt chairman Habil Khorakiwala. "Development of azithromycin is a reflection of Wockhardt's strong R&D for bulk drugs and formulations. This again is proof of Wockhardt's commitment and dedication to developing innovative technologies, to capture opportunities in the USA".Wockhardt's azithromycin tablets will be launched in the US market immediately. According to IMS, the total market for azithromycin tablets in the US is $0.7 billon equivalent to nearly 250 million tablets. It is used in treating several kinds of infections and is one of the most potent, powerful and safe antibiotics.In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. Wockhardt today markets over fifty products in the US.The azithromycin API is manufactured in the FDA approved API facility at Ankleshwar, Gujarat and the tablets are manufactured at the US FDA certified formulation plant at Aurangabad, Maharashtra. The API and the product were developed in-house.Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API's, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.
Azithromycin History
Azithromycin is an azalide, a subclass of macrolide antibiotics. Azithromycin (brand names Zithromax® in Italy, The United Kingdom, The United States, Australia, Portugal and Belgium; ATM® in India, Vinzam® / Zitromax® in Spain; Zmax®; Sumamed®; Aztrin®, Zitrocin®, Azibiot®, Azifine®,AziCip®) is one of the world's best-selling antibiotics, team of Croatian pharmaceutical company Pliva researchers, Gabrijela Kobrehel, Gorjana Radobolja-Lazarevski and Zrinka Tamburašev led by Dr. Slobodan Đokić, discovered azithromycin in 1980. It was patented in 1981, and was later found by Pfizer's scientists while going through patent documents. In 1986 Pliva and Pfizer signed a licensing agreement which gave Pfizer exclusive rights for the sale of azithromycin in Western Europe and the United States. Pliva brought their azithromycin on the market in Central and Eastern Europe under the brand name of Sumamed in 1988, Pfizer Zithromax in 1991, and Zentiva Azitrox. After several years, the US FDA approved AzaSite®, an ophthalmic formulation of azithromycin, for the treatment of eye infections. AzaSite is currently marketed in the US by Inspire Pharmaceuticals. Azithromycin is commonly administered in tablet or oral suspension (a one-dose version was made available in 2005). It is also available for intravenous injection. Tablets come in 250 mg and 500 mg doses. Oral suspension comes in 100 mg/teaspoon and 200 mg/teaspoon strengths. The 250 mg tablets are often dispensed in packages of six and commonly referred to as a "Z-Pak," whereas the 500 mg tablets are commonly available commercially in a pack of three tablets, or "Tri-Pak," intended as a three-day treatment. A common dose of oral azithromycin therapy consists of a "double dose" of medication on the first day of treatment and subsequent treatment for four or five additional days. With the "Z-Pak," this means two 250 mg tablets (a total of 500 mg) on the first day and one 250 mg tablet once daily for the next four days.
Pfizer brand-name (e.g., Zithromax®) azithromycin tablets are mottled pink, unscored, film-coated, modified-oval-shaped tablets containing azithromycin monohydrate equivalent to 250 mg or 500 mg azithromycin and the following inactive ingredients: butylated hydroxytoluene, calcium phosphate, carmine, colloidal silicon dioxide, FD&C red # 40 lake, FD&C yellow # 6 lake, hypromellose (2910, 15cP), lactose monohydrate, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, talc, titanium dioxide and triacetin. The 250 mg tablets have the following appearance: They are mottled pink, of a modified-oval-shape, and have "Pfizer" engraved into one side with "306" engraved into the other. The 500 mg tablet is similar in appearance with the exception of its relative size and "ZTM500" engraved onto one side with "Pfizer" on the reverse. As with all medications, generic azithromycin tablets produced by companies other than Pfizer without the Zithromax brand name may have different appearances. For instance, the generic azithromycin sold under the Greenstone brand is pink, with the hexagonal "G" Greenstone, Ltd. logo engraved on one side and the numerals 3060 on the other.
Brand name Zithromax in Greece and Cyprus is sold in boxes containing a blister of six white 250mg capsules. On the capsules there is printed the "Pfizer" logo and the symbols "ZTM 250".
Azithromycin is now available with microcencapsulated in betacyclodextrin, in India with the brand name of VRENTROX-DS and VENTROX-250. It is also available in India under brand name Azivista-500 in a three dose pack of 500mg each and is manufactured and sold by Cadilla pharmaceuticals.
