Re: {LONGTERMINVESTORS} DR. REDDYS .............Thread
RAJESH DESAI
Dr. Reddy's Laboratories (DRL) said the United States Food and Drug Administration (USFDA) has lifted the import alert at the company's chemical manufacturing facility at Cuernavaca, Mexico. DRL's Mexico facility was inspected by USFDA in November 2010. Based on observations by the USFDA, a warning letter was issued on 14 June 2011 to the company. DRL later worked with USFDA to resolve the observations in the warning letter. An inspection report after the last inspection in March 2012 indicated that USFDA was satisfied with all the outstanding action points that DRL had submitted. With the satisfactory closure of observations in the warning letter and the lifting of the import alert, DRL can now start importing products to the US from this facility, DRL said in a statement. DRL's Mexico facility produces intermediates and active pharmaceutical ingredients.
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Karishma Suvarna
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CA. Rajesh Desai
RAJESH DESAI
Dr Reddy's Laboratories announced today that it has launched Amoxicillin Tablets Capsules, and Oral Suspension, a bioequivalent generic version of Amoxil® (Amoxicillin) Tablets, Capsules, and Oral Suspension in the US Market on September 17, 2012. Amoxicillin Tablets (500 mg and 875 mg), Capsules (250 mg and 500 mg), and Oral Suspension (125 mg/5 ml, 200 mg/5 ml, 250 mg/5 ml, and 400 mg/5 ml) are approved by the United States Food and Drug Administration (USFDA).
The Amoxil brand and generic Tablets (875 mg) has U.S. sales of approximately $22.2 million, Capsules has U.S. sales of approximately $67.2 million, and Oral Suspension has U.S. sales of approximately $89.5 million, all for the most recent twelve months ending June 2012 according to IMS Health.
Dr. Reddy's Amoxicillin Tablets in 500 mg and 875 mg are available in bottle counts of 20 and 100. Amoxiciliin Capsules in 250 mg and 500 mg are available in bottle counts of 100 and 500. Amoxicillin Oral Suspension in 200 mg/5 ml and 400 mg/5 ml are available in bottle sizes of 50 ml, 75 ml, and 100 mi. Amoxicillin Oral Suspension in 125 mg/5 ml and 250 mg/5 ml are avaiiable in bottle sizes of 80 ml, 100 ml, and 150 mi.
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CA. Rajesh Desai
RAJESH DESAI
Dr Reddy’s Laboratories has launched Montelukast Sodium Oral Granules, a bioequivalent generic version of Singulair (Montelukast Sodium) oral granules in the US market, following the approval by the United States Food & Drug Administration (USFDA) of its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Oral Granules.
The Singulair Oral Granules brand had US sales of about $61 million for the most recent twelve months ending July 2012 according to IMS Health. The company’s Montelukast Sodium Oral Granules in 4mg are available in unit dosage package of 30.
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CA. Rajesh Desai
RAJESH DESAI
The Custom Pharmaceutical Services (CPS) business of Dr Reddys Laboratories has expanded its footprint in the areas of activated mPEG manufacturing and in the development and manufacture of NCE (New Chemical Entities) APIs for use in pre-clinical through to commercial development all its manufacturing facility in Mirfield, UK.
The expansion puts the company at the forefront of activated mPEG manufacturing and will enable manufacture of its PEGtech range at commercial metric tonne quantities and beyond in a fully cGMP environment. Equipped with state-of-the-art DCS control systems, the plant operates with a very high level of control and has been designed with the latest manufacturing compliance standards in mind.
Dr Reddy's is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - the company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, bio-similars, differentiated formulations and NCEs.
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CA. Rajesh Desai