Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Dexamethasone Sodium Phosphate Injection (ANDA 084282)
The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.
Regulatory Updates
Sep 20, 2026•1 min read
KPA and MFDS to Hold Parametric Release Training for Sterile Product Manufacturers on Sep 29
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.
Regulatory Updates
Sep 17, 2026•1 min read
MFDS reports 7 GMP observations for Kyungbang Shinyak, all classified as "Other"
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.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090007 for Generic Gabapentin Capsules
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.
Regulatory Updates
Sep 14, 2026•1 min read
Korea United Pharm’s Sejong Plant Retains GMP Certification after Ukrainian Inspection
Korea United Pharm announced that its Sejong‑1 plant passed a re‑inspection by Ukraine’s drug regulator, maintaining its GMP certification.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA209102 for Generic Baclofen Tablets
The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA079162 for Topiramate Generic Tablets
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.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Recalls Drug Over Adulterated API and Content Uniformity Failure
The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Recall: Products Exposed to Improper Temperatures (D-0179-2024)
The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Recalls All Compounded Sterile Preparations Due to Sterility Assurance Issues
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.