We Make Healthcare
Understandable, Accessible and Affordable.
R & D Biotechnology
REGULATED MARKETS
Daser Tekstil manufactures and delivers a range of immunosuppressant finished products to the USA market. Our collaborative business approach enables us to capitalize on our expertise in product development and manufacturing, while our partners contribute their strengths in marketing.
Having successfully introduced ANDAs in the USA, we possess a robust pipeline of products slated for commercialization in the near future, ensuring sustained growth. Furthermore, we are actively exploring opportunities to collaborate with companies across different regions through various business models such as out-licensing and co-marketing. Our aim is to provide patients with high-quality, bioequivalent finished products, extending our commitment to enhancing healthcare accessibility globally.
| Sr. No | Product Name | ANDA# | Approval Date | Pack Style |
|---|---|---|---|---|
| 1 | Mycophenolate Mofetil Capsules, USP 250mg | 210181 | 8-Jan-19 | 100 counts in HDPE bottles 500 counts in HDPE bottles |
| 2 | Mycophenolic Acid DR Tablets USP, 180 mg and 360 mg | 211173 | 13-Dec-19 | 120 counts in HDPE bottles |
| 3 | Mycophenolate Mofetil Tablets, USP 500mg | 212087 | 31-Jul-2020 | 100 counts in HDPE bottles 500 counts in HDPE bottles |
| 4 | Tacrolimus Capsules USP, 0.5, 1 and 5 mg | 213112 | 10-Nov-2020 | 100 counts in HDPE bottles |
What we do
01. Biopharma Solutions:
02. Biotech Advancements:
03. Biochemical Marvels:
04. Ayurveda Elixirs:
05. Medical and Healthcare Excellence:
06. Research-Backed Formulations:
FORMULATION: EMERGING MARKETS
Daser Tekstil maintains a worldwide presence spanning approximately 70 countries, with a primary focus on the USA, Asia, and Africa. Additionally, we have established a joint venture company in Japan.
Our company employs a targeted go-to-market strategy that combines partnership presence and a distributor model, enabling us to effectively navigate diverse market dynamics and offer our niche product portfolio on a global scale.
Daser Tekstil specializes in the manufacturing and distribution of immunosuppressant finished products across global markets. Supported by a robust product development and regulatory team, we are equipped to assist our partners in navigating the intricate and dynamic regulatory landscapes across various markets. Committed to upholding cGMP standards and undergoing inspections by leading regulatory bodies such as the USFDA and others, Daser Tekstil prioritizes delivering high-quality finished products at accessible pricing to meet patient needs.
With a robust pipeline of products, Daser Tekstil aims to sustain its growth trajectory in global markets by expanding market reach and implementing a strategic approach.
| Sr. No | Brand Name | Generic Name | Dosage | Strength |
|---|---|---|---|---|
| 1 | Mofecon C | Mycophenolate Mofetil | Capsules | 250mg |
| 2 | Mofecon 500 | Mycophenolate Mofetil | Tablets | 500mg |
| 3 | Mofecon OS | Mycophenolate Mofetil | Suspension | 1g/ml |
| 4 | Mofecon S 180 | Mycophenolate Sodium | Tablets | 180mg |
| 5 | Mofecon S 360 | Mycophenolate Sodium | Tablets | 360mg |
| 6 | Tacrolimus 0.5 | Tacrolimus | Capsules | 0.5mg |
| 7 | Tacrolimus 1 | Tacrolimus | Capsules | 1mg |
| 8 | Tacrolimus 5 | Tacrolimus | Capsules | 5mg |
FORMULATION: CONTRACT RESEARCH & MANUFACTURING
Daser Tekstil offers formulation development and contract manufacturing services tailored to meet your needs.
Our cutting-edge formulation facility is certified by the DSIR (Department of Science & Industrial Research) in Turkey and is staffed by a team of experienced senior scientists. These professionals specialize in developing complex drug products that adhere to stringent global regulatory standards, ensuring safety, efficacy, and effectiveness.
The Formulation Development facility is divided into two key divisions:
- Formulation Development Laboratory
- Analytical Development Laboratory
Within these divisions, we undertake a range of major activities to support your projects.
Pre-formulation Development
Daser Tekstil initiates pre-formulation development with the objective of gathering essential information crucial for developing bioavailable dosage forms. This comprehensive study encompasses various parameters, including the physicochemical properties of the drug (such as solubility, partition coefficient, dissolution rate, stability, and solid-state analysis like polymorphs and particle size), establishment of kinetic rate profiles, and excipient compatibility studies.
Formulation Development
Equipped with state-of-the-art capabilities and resources, our R&D department specializes in formulating a diverse array of sterile and non-sterile dosage forms. These include Solid Orals (Tablets & Capsules), Oral Liquids, Oral Suspensions, Lyophilized formulations, and Sterile Injectables. Daser Tekstil is actively engaged in multiple Contract Research & Manufacturing projects with leading global pharmaceutical companies, leveraging our expertise to deliver innovative solutions.
Analytical Development
Daser Tekstil’ Formulation Development Laboratory is complemented by our Analytical Development Laboratory, which conducts various activities in accordance with GLP requirements:
- Pre-formulation studies, including assessments of solubility, forced degradation, and excipient compatibility.
- Development, validation, and transfer of analytical methods.
- Bio-relevant dissolution studies to aid in formulation selection.
- Development of discriminatory dissolution methods based on factors such as solubility, pKa, ionization state, and excipients.
Our laboratory is equipped with state-of-the-art instruments, including HPLC, GC, GC-HS, dissolution apparatus, FTIR, and more, enabling us to conduct precise and reliable analyses to support formulation development and regulatory requirements.