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After implementation of the process improvements and changes in the API suppliers, the Formulation WG confirmed the decrease of impurities in these generic products to a level comparable to those in the original product.
Finally, it would help if the clients paid on time: the example of PEPFAR and its Supply Chain Management System, who pays within 45 days, which in turn enables formulators to pay their API suppliers in 90 days, and generates positive cash flow, was cited as a positive example and practice to be emulated.
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Although the newly supplied API corresponded to the requirements of the current specification, after the change of the API supplier it was found that the drug formulations hardly met the required specification.
Firstly a sample of the API from the original supplier (AP-3) and two different samples of the API from the new supplier (AS-1 and AS-2) were analysed in detail.
Subsequently two new batches of the API from the new supplier manufactured according to these criteria and the tablets produced from these APIs (AS-4/TS-4 AS-5/TS-5Tsubjected subjectod to all the above mentioned tests, and critical parameters were suggested.
The sample of the API from the original supplier and its final peroral dosage form were used as standards (AP-3 and TS-3), and based on the parameters of this API (sample AS-3) some criteria were advised.
A change of the supplier of the API for an older medicament led to noncomplying results of the dissolution test (samples TS-1 and TS-2).
This case study discusses prompt determination of critical parameters of the API purchased from a new supplier to afford the drug formulation to conform to the valid specification.
Moreover, it claimed that the supplier of the bulk API had improved the process to avoid contact with water and was storing the material in improved storage bags, less permeable to water.
The current best cost for the API is about $120 per kilogram from Indian generic suppliers.
All the samples of APIs (AS-1 AS-5), thAS-1 AS-5ve differenthattches, were receised five external suppliers; samples AS-1, AS-2, AS-4, andifferentre from a new supplier and sample AS-3 was from a previous supplier.
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