BACHEM AMERICAS INC

TASK ORDER AWARD. CHEMISTRY, MANUFACTURING AND CONTROLS AND RELATED SERVICES FOR DEVELOPMENT OF DRUG SUBSTANCES. 3-YEAR STABILITY STUDY EXTENSION ON THE PTH-IA CGMP BATCH

TASK ORDER AWARD. CHEMISTRY, MANUFACTURING AND CONTROLS AND RELATED SERVICES FOR DEVELOPMENT OF DRUG SUBSTANCES. 3 YEAR STABILITY STUDY EXTENSION ON THE L-ENK GMP BATCH (LOT 1000048945)

TO ADMINISTRATIVELY DE-OBLIGATE UNEXPENDED AND EXPIRING FISCAL YEAR 2020 FUNDING IN ACCORDANCE WITH 31 U.S.C. SECTION 1552 (A), IN PREPARATION FOR SEPTEMBER 30, 2025, CLOSING OF THE PERIOD OF AVAILABILITY OF THESE FISCAL YEAR FUNDS.

EXTENDED STABILITY STUDIES OF PTH-IA

HAVE BACHEM ISSUE QA REVIEWED COAS OF GMP DRUG SUBSTANCE PTH-IA AND ITS QUALITATIVE REFERENCE STANDARD AND ASSIGN A NEW RETEST DATE BASED ON THE STABILITY STUDY RESULTS. ANOTHER PURPOSE IS TO HAVE BACHEM PERFORM AN EXTRA STABILITY STUDY TESTING ON TH

MANUFACTURE OF 150 GN OF CGMP PTH-IA

MANUFACTURE OF 150 GN OF CGMP PTH-IA