Operating under the ideal of being “a trusted, global institution abiding by universal values” and the objective of “creating pioneering and innovative products improving the quality of life by efficient use of resources”, Nobel İlaç is one of the pharmaceutical companies with the highest rate of growth in the last decade.

  • Manufacturing
  • R-D

Our Quality Policy

As a company practicing the GMP requirements, it is our policy to be able to keep fast pace with technological and standard changes in the sector, improve the qualities of the qualified personnel we have recruited, use all available sources effectively and increase productivity, maintain improvement in the issues of customer satisfaction, and gain entrance to our target markets by sustaining our relevance as a professional contract manufacturer of pharmaceuticals in the international context.

Our Environment Policy

It is our policy to be “an environment-friendly business” complying with national and international environmental laws and regulations, and establish, practice and continuously develop an environment management system to be continuously applied in all of our activities in the fields that we produce products and services in order to protect the ecosystem by preventing unnecessary utilization and pollution of resources globally.

To this end, it is Nobel’s responsibility to;
Protect natural sources: Use technologies that provide effective use of natural sources, that create less or no waste to the extent permitted by our financial capabilities,

Reduce wastes: Reduce wastes at source, recycle, provide disposal through appropriate methods by expert companies without harming the environment,

Remain up to date: Operate in accordance with the most current regulations to the extent permitted by our sectoral requirements by following the changes in environmental laws and regulations relating to our fields of business,

Continuously improve the system: Strive to realize our periodic targets by continuously reviewing and improving our environmental management system in the framework of our technological and financial capabilities, without restricting ourselves with laws and regulations,

Try to improve environmental awareness: Keep communicating with suppliers, subcontractors and customers through information sharing in order to encourage them to be environment aware, make environmental awareness a criterion for making business with individuals and institutions, contribute to the improvement of environmental awareness of our employees through trainings and our exemplary activities,

Be open: Keep all our activities relating to environment accessible, announce the obtained results and the new objectives.

Types of Manufacturing

Solids : Powder, Granule, Tablet, Film Coated Tablet, Dragee

Liquids : Drop, Solution, Syrup, Emulsion, Suspension

Semi Solids : Ointment, Pomade, Gel

Cephalosporins : Powder, Granule, Tablet, Film Coated Tablet, Sterile Injectable Vial

Our Services

Manufacturing of Medicines for Human Use

Our factory is a professional contract manufacturer subject to the audit of the Ministry of Health, as well as frequently undergoing foreign audits. All products are manufactured under a quality system established in line with the cGMP rules and with appropriate equipment. Manufacturing methods and formulations are applied by performing all in-process controls in accordance with the instructions of the customer and released for sales following the performance of the analyses pursuant to the drug product specifications provided by the customer.

Manufacturing Analysis

In addition to performing manufacturing analyses, our Quality Control Laboratory also provides independent analytical services.

  • All chemical substance and drug analyses (moisture assays, assays, impurity analyses, identification tests, HPLC, UPLC, GC, KF, NIR with routine test equipment)
  • Water chemical analyses
  • Water microbiological analyses
  • Air microbiological analyses
  • Air particulate counts
  • Microbiological analyses for personnel, environment, food, etc. and all oher analyses that can be performed by using the available infrastructure can be appropriately conducted in our laboratory.

Manufacturing Validation

All new products are validated in compliance with the cGMP rules and revalidated periodically, which is a part of the manufacturing service.

Stability Analyses

Included in the contract manufacturing service that we provide, this task is performed by routinely monitoring each manufactured product under stability.

Analytical Method Validation

Through this task, which is included in the contract manufacturing service that we provide, all analytical methods used are validated by the globally valid, most recent procedures, and the reliability of test results are ensured.

Pharmaceutical R&D

  • Composed of an experienced team in the field of generic formulation research and development.
  • Project-based studies are performed at Fargem Pharmaceutical Formulation Department in line with customer requests.
  • Pharmaceutical formulation department has the sufficient knowledge and experience for developing solid, semi-solid, liquid, sterile and non-sterile formulations.
  • Fargem Formulation Department has the experience for developing conventional dosage forms, modified release systems, delayed release systems, orodispersible tablet formulations, flash tablet formulations, micropellet formulations and effervescent formulations.
  • Fargem Formulation Department continues its studies on developing new drug release systems.
  • Fargem Formulation Department takes part in performing pilot and scale-up productions of the formulations it developed and provides support in the performance of process validations for commercial production of formulations developed.
  • Fargem Formulation Department provides service for developing generic drug formulations, new release systems and bringing economical solutions to manufacturing problems with its experienced team and sufficient technical equipment.
  • Fargem Formulation Department provides support in the preparation of the necessary documentation throughout the registration process of formulations it developed.

Analytical R&D

  • Following are performed for products developed in the Formulation Development Department of the Analytical R&D Laboratory operating with cutting-edge technology and substantial background knowledge:
  • Dissolution rate
  • Solubility
  • Assay
  • Impurity
  • Incompatibilities
  • Stability analyses as per ICH rules
  • Photostability analyses
  • Analytic method development and validation of the methods developed
  • Drug substance and excipient analyses
  • Degradation and impurity identification analyses.

Synthetic R&D

Operating under Ulkar Holding, FARGEM Synthetic R&D Department essentially performs research and development activities for generic API synthesis. In parallel to these studies, work is also being done for developing new methods for generic drug API synthesis, investigating crystal forms, determination, synthesis and structural elucidation of API impurities. In this respect, research and development studies relating to industrial-scale synthesis of many APIs in the market have been completed in FARGEM Synthetic R&D Department. Many of these studies are patent protected.

Besides R&D studies relating to generic drug API synthesis, studies are also performed at FARGEM Synthetic R&D Department relating to the design, synthesis and activity investigation of originator drug candidate molecules. Through such projects, it is planned to quickly obtain candidate compounds that complete preclinical pharmaceutical development ready for Phase I development step.

The Synthetic R&D Department where all of these R&D operations take place keeps up with world standards in terms of equipment and laboratory capabilities. In addition to laboratories relating to synthesis studies, the Cell Culture Laboratory for pharmaceutical activity investigation is also in active state. Many instrumental analyses such as IR, NMR, HPLC, UPLC, GC, LC-MS/MS, LC-HRMS, and UV are actively utilized in the studies at synthesis laboratories.

Basic Drug R&D

Phases of drug research and development can be classified into two groups: First is basic drug research, and the second one is clinical research. Field of activity of the basic drug R&D department encompasses the research operations in the first group. In this context, work field of this department includes novel drug development, pharmacodynamic studies, toxicologic studies, biological activity determination methods. Today, novel drug research and determination of biological activities of novel drug candidates are performed by basic drug research and development department

Quality Assurance

  • Establishing a quality system
  • Ensuring compliance with GMP and GLP requirements
  • Preparing the necessary SOPs
  • Reviewing and approving process and analytical validations
  • Implement method transfers
  • Implement technology transfers

Cell Culture

At Fargem, which has the only cell culture laboratory in Turkish pharmaceutical industry, the Cell Culture Laboratory has the necessary infrastructure and the team for performing permeability studies.

Primary fields of interest at Fargem Cell Culture Laboratory can be classified into two titles: One is Caco-2 (Human colon adenocarcinoma cell line) permeability measurement and PAMPA (Parallel Artificial Membrane Permeability Assay) which are the commonly preferred methods for testing intestinal absorption of originator drug candidates taken orally prior to clinical administrations. These two methods are applied at Fargem Cell Culture Laboratory in combination with each other.

The other field of interest of our laboratory is the application of biological activity testing of original compounds newly synthesized at Fargem.

Services

  • Formulation Development
  • Analytical Method Development
  • Documentation
  • Bioequivalence