규제 업데이트

The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.

The Korea Pharmaceutical Bio Association and the Ministry of Food and Drug Safety will host a technical training on parametric release for final sterilized product manufacturers on September 29 in Cheongju.

The Ministry of Food and Drug Safety disclosed that Kyungbang Shinyak received seven GMP observations in facility equipment and manufacturing, all categorized as "Other" with no major issues.

FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.

Korea United Pharm announced that its Sejong‑1 plant passed a re‑inspection by Ukraine’s drug regulator, maintaining its GMP certification.

The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.

The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.

The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.

The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.

The FDA is initiating a recall of all compounded sterile preparations still within their expiration dates because poor sterile production practices have compromised sterility assurance.