Morepen Labs Limited has received a fresh USFDA approval for its API (Active Pharmaceutical Ingredient) manufacturing facilities at Masulkhana, HP. The facility is currently manufacturing their blockbuster drug Loratadine for the US market, for which it had received an approval by the FDA in March'99. The inspection for the current approval was the first after the drug went off patent in Dec'02 and commencement of supplies.

According to Mr.Sushil Suri, CMD, Morepen Laboratories Limited, "The fresh USFDA approval comes at a time when the company is consolidating its operations and further planning to boost its turnaround efforts. The debt restructuring talks with the bankers are also at an advanced stage of consideration. "

Loratadine is the largest selling anti-histaminic in the world and Morepen Labs commands more than 90% share of the US generic market outside the innovator. It has large regular supply contracts to top rated companies like Novartis and Merck.

To leverage on the USFDA approved infrastructure at Masulkhana, Morepen has added two more products to the same facility. These two molecules Citalopram and Sertraline are anti-depressant drugs that command a combined market size of $4.25 billion. The Drug Master Files (DMFs) for them are expected to be filed in the next 6 months.

At its new API facility at Baddi (HP) preparations are underway for seeking USFDA approval. The company is planning to manufacture three anti-hypertensive drugs at this facility. These drugs, Benazepril, Lisinopril and Ramipril are collectively valued at $2.83 billion.

Morepen, a traditional API player, is now moving up the value chain and is setting up a large sophisticated base for Finished Formulations in Baddi as per USFDA guidelines. This plant will serve as a contract-manufacturing base for regulated markets, which the company will enter on the strength of its own ANDA filings. As a USFDA approved back-end manufacturer, Morepen is also open to taking up manufacturing for customers who have their own ANDA approvals in hand.

By graduating from being an API source to supplying finished dosage forms, the new Morepen positioning will be as a "neutral" contract manufacturer. By not launching it's own brands in the developed markets Morepen will not compete with its customers and offer them price and quality advantages for finished dosage supplies.

As an integral part of this strategy, Morepen will also offer Co-Development and Contract Research expertise for new initiatives both for API and Finished dosage forms. This model is highly focused and narrow, optimizing on the core competency and basic manufacturing research capabilities of the company.

With a strong API back up, Morepen hopes to leverage it's cost effectiveness and strength in meeting regulatory requirements and position itself as a neutral contract manufacturer. With a focus on expired or near expiry established molecules, the Morepen strategy involves less litigations costs, which will ultimately give it a cost advantage, benefiting customers.

Morepen has already short listed 30 molecules for filing ANDA's over the next five years. The strategy is to focus on a few lifestyles therapeutic segments such as Cardiovascular, Diabetes, Neuropsychiatry, Asthma and Allergies and a few other select categories. All these categories are large and growing and they represent lifestyle chronic diseases that have long-term treatment therapies. A number of molecules are going off patent in the next few years in these segments.