PharmGen Science said Tuesday that it has secured bioequivalence for 19 ingredients in 29 major products, expecting additional revenue of 20 billion won ($14 million).

It said that this additional revenue forecast stems from the government's tightened drug regulations.

In June 2020, the government announced that it would cut drug prices by 15 percent in batches for generic products with the same ingredients as original drugs if pharmaceutical companies do not meet two conditions by February 2023.

The gist of the two conditions calls for maintaining previous prices if targeted companies submit proof of equivalence obtained from self-conducted bioequivalence tests and the raw material usage data registered in the Drug Master File (DMF). Companies can easily meet the requirements for using DMF-registered raw materials by changing raw materials. However, the bioequivalence test is expensive, time-consuming, and difficult to prove, according to PharmGen.

PharmGen said it managed to meet the deadline and avoid drug price cuts while many others still struggle to do the same.

Furthermore, based on the successful results of the bioequivalence testing, PharmGen revealed plans to begin self-manufacturing products that had previously been entrusted to other companies.

The company expected the success would also facilitate its contract manufacturing organization (CMO) business under the “1+3 scheme,” which allows it to supply products to the trustees of up to three companies.

"We are pleased to announce the bioequivalence of 29 items in just two years of the government’s announcement," a PharmGen Science official said. "We will continue improving productivity by making bold investments in production facilities for the in-house production and CMO production of new products while reducing costs."