The drug regulator ordered Korea Pharma to suspend manufacturing of medicines including steroid cream, saying the drugmaker violated the Good Manufacturing Practices (GMP).

 On Aug. 30, the Ministry of Food and Drug Safety ordered Korea Pharma’s manufacturing suspension due to the company’s violation of the Pharmaceutical Affairs Act.

 Specifically, Korea Pharma is banned from producing Lacticare HC Lotion 1% (ingredient: hydrocortisone), Lacticare HC Lotion 2.5%, Lacticare Jemazis Lotion 0.25% (prednicarbate), and Zeromu Nail Lacquer (ciclopirox) for three months from Sept. 15 to Dec. 14.

 Also, the regulator suspended the manufacturing of Pharma Mecobalamin Tab. (mecobalamin) and topical liquids for one month from Sept. 15 to Oct. 14.

The regulator said Korea Pharma wrote a false report on testing lactic acid, an excipient ingredient of Lacticare HC Lotion, Lacticare Jemazis Lotion, and Zeromu Nail Lacquer.

The drugmaker also made false test records about consigned production items, too.
 When making Pharma Mecobalamin Tab., the company did not comply with its regulations related to deviation from standards and test progress and records.

Of the five items with the GMP violation, Lacticare Jemazis Lotion 0.25% is a prescription drug. It is a steroid formulation for eczema and dermatitis groups (atopic dermatitis, seborrheic dermatitis, contact allergic dermatitis, pseudopsoriasis, lichen planus, and itchy rash) and psoriasis.