FEIYUE Pharmaceuticals Company

Penicillin-class products carry a specific set of documentation obligations. Beta-lactam residues in the API are controlled by the manufacturing site rather than by the formulator, and the written confirmation required for a third-country source under EU Article 46b(2)(b) is the document that ties your dossier to that site. Fixed-dose combinations with a beta-lactamase inhibitor add a second control point: the potency of the inhibitor has to be demonstrated independently, because it is dosed at a fraction of the primary agent and a small drift is not visible in the finished product assay. Importers should ask which combination partner is used and whether the two actives are sourced from the same site or from two. A solid oral dosage form supplied as hard gelatin capsules, filled on GMP-certified encapsulating lines with in-process control for fill weight and sealing integrity. Available as standard white or coloured capsules with optional film coating.

Amoxicillin Capsules is manufactured in a GMP-certified facility, and every batch of 125mg / 250mg / 500mg is released with a Certificate of Analysis issued against the registered specification for this capsules. Documentation for registration in your market — CTD or ACTD dossier, Certificate of Pharmaceutical Product, Certificate of Free Sale — is prepared on request and reviewed by our own regulatory affairs team. Availability, registration status and shelf life for Amoxicillin Capsules in your market are confirmed before any quotation is issued.

Amoxicillin Capsules 125mg / 250mg / 500mg is supplied in Capsules presentation. Production is scheduled against a minimum order quantity of 500,000 Capsules, with a standard lead time of 45 to 55 days from receipt of a purchase order to despatch, calculated from the point at which the production slot is confirmed. Packaging is offered in 10 capsules / blister, 10 blisters / box, 100 boxes / carton. Documentation for this product in your market is prepared on request, and the availability of a registration file, the batch documentation format and the declared shelf life are confirmed in writing before a commercial commitment is made.

Specifications