Service under Ulkar Holding Umbrella

Manufacturing of Human Medicinal Products
Our factory is a professional contract manufacturing site and subjected to audits by the Ministry of Health. Apart from this, our factory is frequently audited by foreign authorities. All products are manufactured with suitable equipment, utilizing the quality system established in line with the cGMP rules. Manufacturing methods and formulations are implemented as they are provided by the customer by making all in-process controls and the products are released to the market after being analyzed in line with their corresponding finished product specifications.
Manufacturing Analysis
Our quality control laboratories provide independent analysis services in addition to manufacturing analyses.
• All chemical substance and pharmaceutical analyses (Humidity assay, Tests, Impurity Analyses, Identification Tests, HPLC, UPLC, GC, KF, NIR, and with routine test devices)

• Water chemical analyses
• Water microbiological analyses
• Air microbiological controls
• Air particle counts
• All microbiological analyses regarding personnel, environment, foods, etc., and all other analyses that can be conducted using the current infrastructure can be conducted in our laboratory.

Validation Manufacturing
All new products are validated in line with the cGMP rules and subjected to revalidation in regular periods. It is a part of the manufacturing service.
Stability Analyses
A part of the contract manufacturing service, this service is conducted via the routine stability monitoring of all manufactured products.
Analysis Management Validation
Included in the contracted analysis service, this service ensures that all analysis methods used in manufacturing are validated with the latest methods in the world and therefore, the reliability of the test results is guaranteed.