Schering GMP investigation
Executive Summary
FDA/Justice Department investigation of Schering-Plough's GMP compliance at its Manati, P.R. facility is focusing on ribavirin, among other products, firm discloses. The investigation itself was disclosed in May; Schering has not previously identified specific products targeted (1"The Pink Sheet" June 24, 2002, In Brief)...
You may also be interested in...
Schering GMP investigation
The Newark, N.J. U.S. Attorney's Office is spearheading a criminal investigation related to Schering-Plough's Puerto Rico production facilities, Schering confirms (1"The Pink Sheet" May 20, p. 5). The investigation reportedly focuses on use of unapproved raw materials...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.