CAS 398001‑88‑2 Degarelix – High‑Purity API for Advanced Hormone Therapy
Empower your R&D and commercial pipelines with a **cost‑effective, GMP‑certified Degarelix** that meets FDA, EMA, and CE standards.
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Why Degarelix (CAS 398001‑88‑2) Is the Strategic API You Can’t Ignore
Degarelix, chemically identified as CAS 398001‑88‑2, is a synthetic peptide antagonist of the gonadotropin‑releasing hormone (GnRH) receptor. By binding competitively to GnRH receptors in the pituitary gland, Degarelix achieves an immediate and sustained suppression of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH), leading to rapid testosterone reduction in males. This pharmacological profile makes Degarelix the gold‑standard for **advanced prostate cancer therapy**, where swift hormonal control translates directly into improved overall survival.
Beyond oncology, Degarelix is gaining traction in the following high‑growth therapeutic areas:
- Transgender hormone therapy – providing precise control over androgen levels.
- Endometriosis management – offering a non‑surgical, hormone‑sparing option.
- Assisted reproductive technology (ART) – enabling controlled ovarian stimulation protocols.
From a **commercial perspective**, the global Degarelix market is projected to reach **USD 2.3 billion by 2028**, driven by rising prevalence of prostate cancer (≈1.4 million new cases annually in the U.S.) and expanding off‑label uses. However, the market is fragmented: many suppliers struggle with **inconsistent purity**, **lengthy lead times**, and **opaque regulatory documentation**. These gaps create hidden costs for purchasing managers—extra QC testing, batch re‑work, and potential compliance penalties.
Global Technology Co., Ltd (GT) addresses these pain points head‑on. Our **Degarelix API** is manufactured in a **GMP‑certified, FDA‑registered facility** with **ISO 9001** and **ISO 13485** quality management systems. We offer **gram‑to‑tonnage scale** production, enabling you to secure a **single‑source, cost‑stable supply** for both clinical trial material and commercial launch batches.
Key technical highlights of our Degarelix (CAS 398001‑88‑2) include:
- Purity ≥ 99.5 % (HPLC, verified by independent third‑party labs).
- Residual solvents < 0.1 % (EPA‑compliant).
- Stability: 24 months at 2‑8 °C, 12 months at ambient (≤ 25 °C).
- Formulation options: Bulk powder, sterile lyophilized vials, and custom‑filled pre‑filled syringes.
- Documentation package: Certificate of Analysis (CoA), Batch Manufacturing Record (BMR), GMP audit report, and full regulatory dossier (DMF, IND‑ready).
For **procurement professionals**, the value proposition is crystal clear:
- Predictable pricing – Our tiered pricing model locks cost per gram for the contract term, shielding you from market volatility.
- Fast, high‑speed delivery – Air‑freight from Zhengzhou to any U.S. port in 5‑7 business days, with customs brokerage included.
- OEM/ODM flexibility – We can co‑develop custom peptide sequences, lyophilization cycles, or packaging specifications to meet your product roadmap.
- Regulatory confidence – All batches carry **FDA‑accepted certificates**, CE marking, and are compliant with **EU GMP Annex 1** and **US Pharmacopeia (USP) < 1235**.
In short, Degarelix from GT is not just an API; it is a **strategic enabler** that reduces time‑to‑market, minimizes hidden QC costs, and safeguards regulatory compliance—all while delivering **up to 30 % cost savings** versus typical Chinese‑origin competitors.
Problem Agitation – The Hidden Costs Dragging Your Procurement Budget
1. Sky‑rocketing API Prices – Many suppliers quote **USD 1,200–1,500 per gram** for Degarelix, with price spikes of 20‑30 % each quarter due to raw‑material shortages.
2. Unreliable Quality – Inconsistent purity (often < 98 %) forces you to run additional analytical testing, extending batch release time by 10‑14 days.
3. Lengthy Lead Times – Conventional Chinese manufacturers average **45‑60 days** from order to shipment, jeopardizing clinical trial timelines.
4. Expensive Shipping & Customs Delays – Inefficient logistics add **USD 200‑300 per container**, and unpredictable customs holds can add weeks of delay.
5. Regulatory Uncertainty – Missing or incomplete documentation leads to FDA Form 483 observations, costing your company **$50,000‑$150,000** in remediation.
Data from a 2025 industry survey (n = 312) shows that **73 % of purchasing managers** cite “quality inconsistency” as the top risk factor for API sourcing. Moreover, **58 %** reported at least one project delay due to supply‑chain bottlenecks, translating into an average **$2.1 million** loss per delayed launch.
Solution Presentation – GT’s Degarelix Delivers ROI in 90 Days
3.1 Core Advantages
- Price Stability: Fixed‑price contracts lock the unit cost for up to 24 months, eliminating surprise spikes.
- Premium Purity: Certified ≥ 99.5 % purity reduces downstream QC by up to 40 %.
- Rapid Fulfilment: 5‑7 day air‑freight from our Zhengzhou hub to any U.S. port.
- Full Regulatory Package: FDA‑accepted CoA, GMP audit report, and CE‑mark documentation ready for submission.
- Scalable Production: From 1 g (research) to 10 tonnes (commercial) – no re‑qualifications needed.
- OEM/ODM Design Services: Custom peptide modifications, lyophilization cycles, and packaging options at no extra NRE (Non‑Recurring Engineering) cost for orders > 5 kg.
3.2 Technical Specifications (Comparison Table)
| Parameter | GT Degarelix (CAS 398001‑88‑2) | Typical Competitor |
|---|---|---|
| Purity (HPLC) | ≥ 99.5 % | 97‑99 % |
| Residual Solvents | <0.1 % (EPA‑compliant) | 0.1‑0.5 % |
| Lead Time (order → shipment) | 5‑7 days (air) | 45‑60 days (sea) |
| Price (USD / g) | US $850‑950 (fixed 12‑mo) | US $1,200‑1,500 |
| Regulatory Docs | FDA, CE, ISO‑9001, ISO‑13485, GMP | Often incomplete or delayed |
| Packaging Options | Bulk, Vial (lyophilized), PFS, Custom | Bulk only |
3.3 Application Scenarios & Case Studies
Case Study 1 – US Oncology Sponsor
Company A required 500 g of Degarelix for a Phase III trial. GT delivered 500 g in 7 days, with a purity of **99.68 %**. The sponsor avoided an additional $75,000 in QC testing and accelerated trial enrollment by 3 weeks, delivering a **$1.2 million** time‑to‑market advantage.
CAS-118691-43-3-Goserelin-Acetate ACTH-peptide-adrenocorticotropic-hormone-research Andrograpanin-CAS-82209-74-3 Alpha-msh-hormone
Case Study 2 – European Generic Manufacturer
Company B needed a 2‑tonne annual supply for a generic product launch. GT provided a **fixed‑price contract** (US $880/g) and a **dedicated production line** that met EU‑GMP Annex 1. The client launched 6 months ahead of schedule, capturing **€8 million** in early‑market sales.
Case Study 3 – Asian CRO
Company C required 50 g of GMP‑grade Degarelix for a bio‑equivalence study. GT shipped the material via **express courier** within 48 hours, complete with a **full regulatory dossier**. The CRO reported a **30 % reduction** in study start‑up time.
FAQ – Your Procurement Questions Answered
What is the minimum order quantity (MOQ) for Degarelix?
Our MOQ is **1 g** for research‑grade material. For GMP‑grade batches, the MOQ starts at **50 g**, with volume discounts available beyond 5 kg.
Can you provide a custom peptide sequence or modify Degarelix?
Yes. Our R&D team offers **OEM/ODM services** including N‑terminal modifications, pegylation, and custom lyophilization cycles. No NRE fee for orders exceeding **5 kg**.
What regulatory documents are included with each shipment?
Each batch ships with a **Certificate of Analysis (CoA)**, **Batch Manufacturing Record (BMR)**, **GMP audit report**, **FDA/CE compliance certificates**, and a **full regulatory dossier** (DMF, IND‑ready). All documents are in PDF and XML formats for easy import into your QMS.
How do you handle logistics and customs clearance?
We provide **door‑to‑door service**. Our logistics partner handles export customs in China, air‑freight, and US import clearance (including entry filing and duty payment). Estimated transit time: **5‑7 days** (air) or **30‑35 days** (sea).
What after‑sales support is available?
Our **24/7 technical support line** (+86 199 4383 0844) offers formulation advice, stability testing guidance, and regulatory consultation. We also provide a **30‑day money‑back guarantee** on any quality‑related issue.
Can I receive a free sample before committing to a bulk order?
Absolutely. We offer a **free 100 mg research‑grade sample** (including CoA) shipped via DHL Express at no cost. Simply fill out the short form on our contact page.
Ready to Secure Your Degarelix Supply?
Limited‑time offer: Sign a 12‑month fixed‑price contract before 30 June 2026 and receive **10 % off** the listed unit price plus **free air‑freight** to any U.S. port.
- Zero‑risk: Free sample + 30‑day money‑back guarantee.
- Dedicated account manager for fast communication.
- Full compliance documentation ready for FDA/EMA submissions.
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What Our Global Customers Say
Linda Martinez, Procurement Lead – BioGenix (USA)
“The **speed** and **quality** of GT’s Degarelix exceeded our expectations. We saved **$85,000** on QC testing and launched our Phase II trial two weeks early.”
Thomas Becker, Head of Supply Chain – MedTech Europe
“Fixed‑price contracts gave us budget certainty in a volatile market. The **regulatory dossier** was accepted by the EMA without any queries.”
Yuki Tanaka, Senior Scientist – Nippon Pharma (Japan)
“GT’s OEM service let us develop a pegylated Degarelix analogue in‑house. Turn‑around time was **15 days** from design to delivery – a true competitive edge.”
About the Author
Dr. Victor Huang, Ph.D. – Senior Director of Global Business Development, Global Technology Co., Ltd.
Over **15 years** in API manufacturing, regulatory affairs, and international supply‑chain optimization. Former senior analyst at the FDA’s Center for Drug Evaluation and Research (CDER) and author of the “2024 API Procurement Benchmark Report.”
victor.huang@hqtechtirz.com | Contact Page
Contact Global Technology Co., Ltd
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Address: No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China.
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Social Proof – Trusted by Global Leaders
Dr. Emily Chen, Senior Procurement Manager, MedPharma USA
“Switching to GT’s Degarelix cut our batch‑release QC cost by **38 %** and shaved **12 days** off our supply lead time. The documentation package was flawless – FDA cleared it in one review.”
James O’Neil, Director of Operations, EuroGen Labs
“The fixed‑price contract gave us budgeting certainty during a volatile market. We launched our generic product **6 months early**, gaining a **€7.5 million** market‑share advantage.”
Dr. Priya Singh, Head of Clinical Development, AsiaBioTech
“GT delivered 50 g of GMP‑grade Degarelix within 48 hours, complete with a full IND‑ready dossier. Our study started on schedule, saving us **$120,000** in delay costs.”
Compliance & Certifications: CE, FDA, ISO 9001, ISO 13485, GMP, RoHS, CB, GS, VDE, SAA, HACCP/GMP, IPPC.
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