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Aurobindo get US FDA approval for antibiotic clindamycin generic pills

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Thursday, August 27, 2009, 12:21 This news item was posted in Industry category and has 0 Comments so far.

Indian APIs and generics maker Aurobindo Pharma Ltd has received approval for the antibiotic clindamycin hydrochloride capsules from the US Food and Drug Administration.

Aurobindo’s clindamycin hydrochlorie is a generic equivalent of Pfizer’s Cleocin hydrochloride capsules. Clindamycin is used to treat certain bacterial infections. Cleocin has a market size of about $55 million, the company said in a statement to the stock exchange.

Clindamycin has a similar range of antibacterial activity to the and is useful as an alternative antibiotic in those people who are allergic to penicillins or for infections caused by bacteria called staphylococci that have become resistant to penicillin.

Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin is an antibiotic of the “lincosamide” class and possesses similar properties to its sister compound “lincomycin.”

Clindamycin interferes with the production of proteins that the bacteria need to multiply and divide. This inhibits the ability of the bacteria to grow (bacteriostatic) and therefore stops the spread of the infection. Clindamycin is also active against anaerobes (bacteria that are able to live and grow in the absence of free oxygen).

Clindamycin safely and quickly accumulates at the site of infection while it maintains high concentrations that fight susceptible aerobic and anaerobic bacteria.

Clindamycin is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.

The types of bacteria sensitive to clindamycin makes this drug especially popular for use in oral and periodontal infections, skin infections, and bone infections.
Clindamycin is also helpful against protozoans such as Toxoplasma and Mycoplasma as well as many anaerobic (growing without oxygen) bacteria.

Recently, Aurobindo Pharma received USFDA approval for sumatriptan succinate Tablets 25 mg, 50 mg, and 100 mg – the generic equivalent of GlaxoSmithKline’s Imitrex® Tablets 25mg, 50mg 100mg and are indicated for the treatment of for the treatment of acute migraine headaches and falls under the Central Nervous System (CNS) therapeutic segment. The product has been shipped for commercial launch.

Aurobindo has a total of 101 ANDA approvals (73 Final approvals and 28 Tentative approvals) from USFDA.

Headquartered at Hyderabad, India,Aurobindo Pharma Limited is the largest Active Pharmaceutical Ingredients (API) manufacturer under FDA approved facility. Aurobindo is also one of the leading manufacturers of penicillin & cephalosporine products.The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

Aurobindo is leading manufacturer of generic pharmaceuticals, as well. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics. Aurobindo is marketing these products in over 100 countries.

Recently, Aurobindo’s wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received its third approval from the Therapeutic Goods Administration (TGA), Government of Australia for the registration of simvastatin Tablets 5, 10, 20, 40 & 80 mg tablets.

Aurobindo Pharma received approval from Swissmedic, Government of Switzerland for the license of Cefepime APL for Injection 1g and 2g. Cefepime APL for Injection 1g and 2g falls under the anti-beta-lactam segment and is indicated for Moderate to severe pneumonia, septicaemia, UTI, skin & skin structure infections, intra-abdominal infections. This is Aurobindo’s second product approval from Swissmedic. Earlier, Aurobindo received the license of Finasteride APL Tablets 5mg.

Aurobindo registered a total operating income of Rs 3124.2 crores for the financial year 2008-09, up by 27.7% from Rs 2446.5 crores in the corresponding period last year. The operating profit before Fx stood at Rs 573.2 crores up by 63.0% compared to Rs 351.7 crores, a year ago. During the year, the company has incurred Fx loss of Rs 254.7 crores, which includes loss due to restatement of Foreign Currency Convertible Bonds (net of deposits) of Rs 223.3 crores (gain of Rs 49.6 crores).

Aurobindo expanded its formulation deal with Pfizer in April. Through the pact Pfizer acquired rights to 55 solid oral dose products and five sterile injectable products that it will sell in several countries throughout Asia, Latin America, Africa and the Middle East.

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