Excipients. Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or Strakan’ Specifications where such excipients are not included in a Pharmacopoeia monograph. In all cases, Strakan shall supply to Aptalis a control copy of the Specifications of each excipient for review and approval. Strakan shall, or shall cause its Contract Manufacturer(s), to source excipients from reputable companies previously approved by Strakan.
Appears in 3 contracts
Sources: Commercialization and License Agreement (Aptalis Holdings Inc.), Commercialization and License Agreement (Aptalis Pharma Inc), Commercialization and License Agreement (Aptalis Pharma Inc)