Morepen gets USFDA approvals for its Bulk Drug facilities

Shalini | Myequity news | Date : 30-07-2018 11:30:00 IST

Morepen Laboratories Ltd, has received (USFDA) The United States Food and Drug Administration approvals for both its bulk drugs manufacturingfacilities situated in Himachal Pradesh. While the Baddi facility has got US FDAapproval for the manufacture of bulk drug "Atorvastatin Calcium", a Cholesterolreducing drug, the Masulkhana facility has recently got the nod for manufacturing ananti-asthma bulk drug "Montelukast Sodium" for export to the US market.

The US market size for these two bulk drugs viz.Atorvastatin Calcium and Montelukast Sodium is approximately Rs.5,000 croreand Rs. 2,000 crore respectively. The two APIs collectively contributes around Rs.150 crore annual revenue to the company's topline and constitutes 44 per cent of thecompany's total API business.

The main API facility situated at Baddi (Himachal Pradesh) houses multiple plants formanufacture of different drugs, including Atorvastatin, and is spread across an areaof around 50 acres. The Masulkhana facility of Morepen Labs got its first USFDAapproval for the manufacture of ,Lor at adine' in the year 1999, followed by a other USFDA approval for 'Desloratadine' in the year 2011. Montelukast" is the third APIapproved out of this plant.

Mr. Sushil Suri, Chairman and Managing Director,Morepen Laboratories Ltd. said, "History has repeated itself with the company onceagain securing twin USFDA approvals, without any adverse remarks from the USregulator. With this development in place, the company is set to expand its footholdin the combined Rs. 7,000 crore US market for Atorvastatin and Montelukast.The two APIs will also strengthen company's existing APIs portfolio comprisingLoratadine and Desloratadine in the US market."

Morepen Labs got an initial US FDA clearance for Montelukast Sodium in December2017, based upon approval of customer's ANDA which triggered an inspection of itsMasulkhana facility in 2018. The facility had gone for regular inspection for all thethree products manufactured therein viz. Loratadine, Desloratadine (alreadyapproved) and Montelukast (new approval). Similarly, the Baddi plant was alsoinspected by US FDA for the first time, triggered by a US customer for supply ofAtorvastatin to the US markets. The inspection got concluded this month itself. Thisplant mainly manufactures Atorvastatin amongst other APIs. Following thisinspection, both the facilities of Masulkhana and Baddi have been approved withoutany deficiency and US FDA has not given any adverse remark! observation (i.e. noForm 483 has been issued), besides a complete approval of the two plants' qualityparameters has been accorded.

"with the help of our experienced and dedicated team,we are fully committed to service the regulated markets and fulfil the compliancerequirements for US, European and other global customers. We are continuouslyworking on scaling up our R&D efforts to become a niche player in the globalAPI markets. R&D team of the company is working relentlessly for churning out newtechnologies and innovative processes towards cost reduction and also towards processsimplification." Mr. Suri further pointed out that.

Atorvastatin and Montelukast have shown great growth potential during last 5years, with a CAGR of 25% and 17% respectively. The company expects decentincremental revenues with more US business coming to company's kitty in the comingyears.

The Masulkhana plant was also inspected and approved by the TherapeuticGoods Agency (TGA), Australia in 2015; minor improvements were made in keeping with the TGA requirements. In addition, the plant has received an EU-GMP certification following an inspection by the Slovenian drug regulatory authoritiesin 2013.

About Morepen Laboratories Limited:

Morepen Laboratories Ltd. is a 34-year old, Rs. 600 Cr. pharmaceutical and healthcareproducts company. The company went public in the year 1993 and is currently listed atboth the Bombay Stock Exchange as well as the National Stock Exchange.

Morepen is engaged in the manufacturing and sale of APIs/ Bulk Drugs, HomeDiagnostics, Formulations and OTC products. The company's state-of-the-artmanufacturing facility at Baddi (Himachal Pradesh) comprises a scientifically integratedcomplex of 10 plants, each with a specific product profile.

The USFDA approved plant at Masulkhana is for manufacture of Loratadine, an antiallergydrug - internationally known as Claritin. Desloratadine and the new blockbusterdrug Montelukast is also manufactured at this FDA approved site. The large and spreadout manufacturing facility at Baddi has EU GMP & WHO GMP Standards andmanufactures latest and much in demand APIs like Atorvastatin, Rosuvastatin,Fexofenadine and others for regulated markets of Europe, USA and also for non-regulatedmarkets across the globe.

Morepen Laboratories Limited closed 4.87% up at Rs 33.40

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