AİS Pharma
AİS Pharma, established in 1963, is a leading pharmaceutical company with 61 years of experience, operating in an 8,000 m2 modern manufacturing facility. The company specializes in producing steril and non-steril products, including Sterile Injectable Liquid Vials and Lyophilized Vials, adhering to current Good Manufacturing Practices (cGMP). With a focus on advanced technology, high-quality standards, and customer satisfaction, AİS Pharma offers comprehensive services such as contract manufacturing, product development, and support services to both domestic and international markets. The company emphasizes its commitment to quality, innovation, and customer-centric solutions, making it a preferred partner in the pharmaceutical industry.
Industries
Nr. of Employees
medium (51-250)
AİS Pharma
Products
Sterile injectable liquid vials (contract-manufactured)
Manufacture of sterile injectable liquid formulations in vial format across a range of fill volumes, produced under aseptic, computer-controlled operations.
Lyophilized vial products (contract-manufactured)
Lyophilized (freeze-dried) products in vial format produced with controlled freeze-drying cycles and validated reporting.
Topical formulations (ointments, creams)
Contract manufacture of topical dosage forms including ointments and creams with secondary packaging services.
Liquid oral formulations and syrups
Manufacture of liquid oral dosage forms such as syrups and solutions, with filling and packaging.
Solid oral dosage forms (tablets)
Manufacture of solid dosage forms including tablets and associated packaging operations.
Sterile injectable liquid vials (contract-manufactured)
Manufacture of sterile injectable liquid formulations in vial format across a range of fill volumes, produced under aseptic, computer-controlled operations.
Lyophilized vial products (contract-manufactured)
Lyophilized (freeze-dried) products in vial format produced with controlled freeze-drying cycles and validated reporting.
Topical formulations (ointments, creams)
Contract manufacture of topical dosage forms including ointments and creams with secondary packaging services.
Liquid oral formulations and syrups
Manufacture of liquid oral dosage forms such as syrups and solutions, with filling and packaging.
Solid oral dosage forms (tablets)
Manufacture of solid dosage forms including tablets and associated packaging operations.
Services
On-site production of sterile injectable liquid vials including integrated washing, aseptic filling, capping and terminal sterilization under cGMP conditions.
Freeze-drying services for products requiring lyophilization using equipment with CIP/SIP, broad shelf-temperature control and automated reporting.
Manufacture of topical (ointments), syrups/liquids and solid dosage forms (tablets), plus secondary operations such as boxing and labeling.
Preparation of registration dossiers in CTD format and support for domestic and international product registration processes.
Project lifecycle management including NDA handling, pre-evaluation, quality audits, preliminary quotes, and project initiation.
Support for manufacturing site transfers, process and analytical method validation, and stability study execution.
On-site production of sterile injectable liquid vials including integrated washing, aseptic filling, capping and terminal sterilization under cGMP conditions.
Freeze-drying services for products requiring lyophilization using equipment with CIP/SIP, broad shelf-temperature control and automated reporting.
Manufacture of topical (ointments), syrups/liquids and solid dosage forms (tablets), plus secondary operations such as boxing and labeling.
Preparation of registration dossiers in CTD format and support for domestic and international product registration processes.
Project lifecycle management including NDA handling, pre-evaluation, quality audits, preliminary quotes, and project initiation.
Support for manufacturing site transfers, process and analytical method validation, and stability study execution.
Expertise Areas
- Contract sterile pharmaceutical manufacturing (CDMO)
- Aseptic filling and vial-based injectable production
- Lyophilization (freeze-drying) processing
- Regulatory submission support and CTD dossier preparation
Key Technologies
- Aseptic vial filling systems
- Lyophilization (freeze-drying) equipment
- CIP/SIP cleaning systems
- Peristaltic pump-based filling
News & Updates
Process of starting new projects including confidentiality agreements, project analysis, and evaluation.
Process of starting new projects including confidentiality agreements, project analysis, and evaluation.