Indian generic firm Lupin has received final approval for its amlodipine/benazepril capsules in US.
Lupin’s generic amlodipine/benazepril capsules are the therapeutic equivalent of Novartis’ Lorrel capsules.
US Food and Drug Administration (US FDA) granted approval for amlodipine/benazepril pills in trengths of 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg.
Commercial shipments of amlodipine/benazepril pills have already commenced, Lupin announced in a press release.
Lupin’s amlodipine/benazepril (Lorrel) capsules indicated for the treatment of hypertension.
Amlodipine/benazepril combo pills had annual sales of approximately US$ 1.1 billion for the twelve months ended September 2009, based on IMS Health sales data.
“The approval reflects the confidence and acceptance of our facility by the US FDA,” stated
Nilesh Gupta, group president and executive director of Lupin Limited.
In Jauary, US FDA revoked the ban imposed on Lupin’s manufacturing facility at Mandideep in Madhya Pradesh.
The US FDA had conducted an inspection at Lupin’s manufacturing facility at Mandideep, in October – November 2008.
The US FDA inspection found several deficiencies in the Good Manufacturing Standards (GMP) standards set by the agency and issued Inspectional Observations also known as Form 483 listing all the deviations.
Lupin’s Mandideep facility makes both sterile and non-sterile pharmaceutical manufacturing and sterile active pharmaceutical manufacturing factories.
US FDA has cited Lupin’s failure to maintain production, control, or distribution records and failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products to be sterile.
Lupin’s Mandideep facility also found to be lacking in controls to prevent contamination in defined areas regarding operations related to aseptic processing of products. The plant managers also failed to routinely calibrate, inspect, or check according to a written programme designed to assure proper performance of automatic, mechanical, or electronic systems.
Mandideep facility was re-inspected by the US FDA officials in November 2009. Following the inspection, Lupin has received official communication from the US FDA on the satisfactory resolution of the Warning Letter issued earlier to its Mandideep site.
US FDA inspected two new sites of Lupin at Aurangabad (Liquids) & Indore (Oral Solids and Oral Contraceptives) in the last quarter.
Aurangabad liquid manufacturing facility was found acceptable with no 483’s and Indore was found acceptable with one 483 observation which was satisfactorily addressed before the close of the inspection.
These recent US FDA inspections bring Lupin a step closer to launching liquids and Oral contraceptives in US market.
Earlier, the UK MHRA and the Australian TGA had also conducted a joint inspection of the Mandideep facility and had found it acceptable.
Recently, Lupin Pharmaceuticals, Inc, the U.S subsidiary of Lupin Ltd has received the tentative approval for the company’s Abbreviated New Drug Application (ANDA) for its memantine hydrochloride tablets, 5mg and 10mg from US FDA.
Lupin’s memantine HCl tablets are AB-rated to Namenda (Forest Labs) tablets indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
Namenda had annual sales of approximately $1.1 billion for the twelve months ended September 2009, based on IMS Health sales data.
In December, Lupin Ltd settled all ongoing Hatch-Waxman litigation relating to memantine tablets with Forest Laboratories, Inc.
As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product in January, 2015, or earlier in certain circumstances.
Headquartered in Mumbai, India, Lupin Limited produces a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.
Lupin has significant market share in key markets in the cardiovasculars (prils and statins), diabetology, asthma, pediatrics, CNS, GI, anti-infectives and NSAIDs therapy segments, not to mention global leadership positions in the anti-TB and cephalosporins.
Lupin is considered to be one among the fastest growing top 10 generics players in the two largest pharmaceutical markets of the world – The U.S (ranked 9th by prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%).
Lupin is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS – March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at over 30 % YoY – IMS)
For the financial year ended March 2009, Lupin’s Consolidated Revenues and Profit after Tax were Rs.39,145 million (US$ 851 million) and Rs.5015 million (US$ 109 million) respectively.