Morepen Laboratories Limited (NSE: MOREPENLAB, BSE: 500288) has received USFDA approval for its anti-allergy drug Fexofenadine Hydrochloride that is market in India under the popular brand name Allegra, among others and is the blockbuster drug of the innovator company Sanofi Aventis, France. Fexofenadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever.
The company has tied up for regular supplies of Fexofinadine to one of its top US customers, with which the company has long-standing relations lasting over two decades. The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches. Fexofenadine is a very established anti-allergy drug with market size of around 700MT and is expected to give immediate impetus to the company’s export business.
Morepen is the third-largest exporter of this drug to the world and will move up in the ranks after this approval. The export of Fexofenadine to the highly regulated US market is expected to see multi-fold growth resulting in better profitability margins for the company. The company is having sufficient capacity to service the present demand and is also expanding capacities to become a leading player in the product in the coming years.
Fexofenadine is among the top five leading products of the company and is the fourth anti-allergy drug in Morepen’s product basket, in addition to Loratadine, Desloratadine and Montelukast. Morepen holds a leadership position in the Loratadine group for the last 20 years and was the first to file for marketing permissions in USA markets. Fexofenadine has marketed primarily in two dosage forms 120mg and 180mg and is available to buy over the counter in many countries including the USA, Australia, New Zealand, and certain countries around Europe. It is also used in combination with other anti-allergy drugs like Montelukast for which Morepen has got the largest manufacturing capacity in the world and is already approved in the US market.
Mr. Sushil Suri, Chairman and Managing Director stated, “Approval of anti-allergy drug Fexofenadine (Allegra) by USFDA is an important milestone in the company’s therapeutic journey since it consolidates Morepen’s position in the anti-allergy market with already having USFDA approval for three lead products Loratadine, Desloratadine and Montelukast. It also cements our long-standing relations with our prime customers who have worked with us for two decades and shows their confidence in the company’s product quality and delivery”
This approval of Fexofenadine is the 5th product approved by USFDA at Morepen facilities based at Baddi, in the Solan district of State of Himachal Pradesh. The company has got an excellent track record with the USFDA regulators and have never got any major/critical observations during its inspections. Morepen has a strong portfolio of APIs with a market size of over US$ 42 billion, which is going off-patent over the next 7-8 years and is building additional capacities in a multiphase USFDA expansion as demand for niche molecules and global customers remain stronger than ever and the market size, the company is looking to address, is US$ 42 billion compared to US$ 2 billion currently.
Morepen has been performing extremely well for the last few years and had reported strong quarterly earnings with a stellar performance in Q2’FY22 with a growth of 70 per cent in its consolidated Profits (before tax) at Rs. 46.86 crores. Profit after tax (PAT) for the quarter has jumped 38 per cent at Rs. 37.36 crores. The Quarterly revenues of the company at Rs. 398.17 crores have recorded an impressive growth of 17 per cent during the current quarter as compared to quarterly revenues of Rs. 340.13 crores in Q2’FY21 wherein it had registered a growth of 57 per cent. This is the sixth quarter in a row that the company continues the fast growth trajectory with remarkable gains in the bottom line.