Atosiban API CAS 90779-69-4

Atosiban | Atosiban API | Atosiban acetate cGMP production | Science-Peptide

Need high quality Atosiban Acetate API for formulation production or generic drug declaration? Science-Peptide provides cGMP-compliant Atosiban API CAS 90779-69-4 with mature process, controllable impurity profile, support for China-US-EU declaration and stable supply. Welcome to contact us.

Atosiban, a synthetic peptide oxytocin receptor antagonist, is used to delay preterm labor and is one of the most widely used contraction inhibitors in clinical practice. It is one of the most widely used contraction inhibitors in clinical practice. Compared with traditional beta agonists, atosiban has a higher maternal-fetal safety profile and has been recommended as a first-line drug by clinical guidelines in many countries. science-Peptide, with more than 20 years of experience in the production of peptides, is one of the early companies in China that have developed the process of atosiban APIs. Our atosiban API adopts mature solid-phase synthesis route with robust process and clear impurity profile, and we have provided cGMP-compliant Atosiban API CAS 90779-69-4 for many domestic and foreign pharmaceutical companies to support their formulation production and generic registration.

Atosiban (Atosiban Acetate) is a cyclic peptide consisting of 9 amino acids .It inhibits oxytocin-induced uterine contractions by competitively binding to the oxytocin receptor, thereby prolonging pregnancy and buying time for fetal lung maturation and transit.

Clear mechanism of action: specific oxytocin receptor antagonist, does not interfere with other hormone systems.

High safety: well tolerated by mother and fetus, few cardiovascular side effects.

Clinical status: First-line contraction inhibitor recommended by European and domestic guidelines for the treatment of preterm labor.

Variety of dosage forms: Usually supplied as injectable liquids in both prefilled syringes and multi-dose vials.

With the expansion of the generic drug market, the demand for atosiban APIs continues to grow. High-quality, compliant and stable supply of APIs has become the core demand of pharmaceutical companies.

1. Proven experience in process routing and scale-up
We initiated the process development of atosiban more than ten years ago, and after many rounds of optimization, we have formed a set of mature and robust synthetic routes:

• Solid-phase synthesis: The Fmoc solid-phase synthesis strategy was adopted, and the combination of resin and protecting group was optimized to improve the yield of crude peptide.
• Cyclization process: Precise control of disulfide bond formation conditions, avoiding mismatches and side reactions, ensuring cyclization efficiency.
• Purification method: Multi-step preparative HPLC purification, effective removal of impurities, to ensure that the purity is stable at more than 99%.
• Scale-up production: The process has been successfully scaled up to 100 kilograms, and data from multiple validation batches show a high degree of consistency between batches.

2. Strict quality control, in accordance with cGMP standards
We produce Atosiban API according to cGMP requirements, and each batch is strictly tested:

• Release test: Appearance, content (≥99.0%), purity (HPLC, ≥99.0%), related substances (single impurity ≤0.15%), moisture, residual solvents, bacterial endotoxin, microbial limit.
• Impurity profile control: comprehensive identification of process impurities and degradation products to ensure that the impurity profile is consistent with that of the original research.
• Stability studies: Long-term, accelerated stability data to support a 24-month retest period.
• Method validation: All analytical methods were validated to meet the requirements of ICH Q2.

3. Complete registration documents, supporting the declaration of China, the United States and Europe
We are well aware of the API documentation requirements for generic filing of Atosiban and can provide:

• Process development reports
• Process validation programs and reports
• Analytical method validation reports
• Stability study data
• Heterogeneous Mass Spectrometry Analysis Report
• Structural corroboration information (NMR, MS, IR, etc.)
• Batch production records (complete and traceable)
• Cooperating with clients undergoing on-site audits by pharmacovigilance agencies

4. Reliable supply chain security

• Dual source procurement: key materials (amino acids, resins) have more than two qualified suppliers.
• Strategic stockpiling: Establishment of safety stocks for long lead time materials.
• Continuous production: Multiple production lines can run in parallel to avoid capacity bottlenecks.

5. Flexible modes of cooperation

• Sales of APIs: Provide cGMP-compliant Atosiban APIs to support the production of preparations.
• DMF authorization: We provide DMF file authorization to support customers' generic drug reporting.
• Technology transfer: Processes can be transferred to customer-specific production sites.
• Customized packaging: according to the needs of the preparation, provide different specifications of packaging.

• cGMP manufacturing site (10 acres)
• Comply with US FDA, Europe EMA, China NMPA cGMP requirements
• ISO 9001:2015 certified
• Automated solid phase synthesis plant (100 kg capacity)
• Preparative HPLC purification system
• Freeze-drying workshop (more than 30 square meters)
• Clean area (ISO class 7/8)
• Complete QC laboratory
• Quality system
• Strict change control, deviation management
• Supplier audits and material traceability
• Annual Quality Review
• Coordinate with clients and regulators for on-site audits

1. Mature technology, clear impurity profile
We have accumulated more than 10 years of experience in the production of Atosiban API, and our process is constantly optimized, and the impurity profile is highly consistent with that of the original research. Many customers choose us because of our mature technology and controllable impurities, so that they can take less detours when filing.

2. Compliance systems, which can withstand scrutiny
Our cGMP facilities and documentation systems have withstood inspections by domestic and foreign drug regulatory agencies. Customers have already used our Atosiban API to successfully pass domestic consistency evaluation and EU ANDA approval.

3. Stability of supply and non-discontinuation of stock
We have established a perfect supply chain management system, with dual-source procurement of key materials and sufficient strategic reserves. We have maintained a stable supply of atosiban APIs even during the special period, and have never had any interruption in supply.

4. Declaring support, saving effort
What we provide is not only API, but also a complete set of data and documents to support the registration. Many customers feedback that our packages are of high quality and can be used right away, which saves them a lot of time.

Whether you need Atosiban API for formulation production or preparing a generic drug submission, Science-Peptide can provide you with high quality, compliant and reliable solutions. Our technical and commercial teams look forward to working with you.