Sigmapharm receives FDA approval for generic Amiloride Hydrochloride Tablets, USP 5 mg, based on its ANDA No. 079133. This is our 1st ANDA approval.
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 091004).
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 090462).
Sigmapharm completes its 1st FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 079133.
Sigmapharm files its 1stAbbreviated New Drug Application (ANDA No. 079133).
Sigmapharm fully relocates to a new 60,000 sq. ft. facility located in Bensalem, Pennsylvania. Our new address is 3375 Progress Drive, Bensalem, PA 19020. Our new phone and fax numbers are (215) 352-6655 and (215) 352-6644, respectively.
Sigmapharm moves to a 5,000 sq. ft. facility located at the Oxford Valley Mall in Langhorne, Pennsylvania.
Dr. Spiro Spireas forms a new specialty pharmaceutical company, Sigmapharm Laboratories, LLC (“Sigmapharm”), on March 1, 2005.