Outline (H1‑H3 Levels)
- H1: CAS 302798-54-5 Relugolix API – High‑Purity, GMP‑Certified Raw Material for Fast‑Track Drug Development
- H2: Table of Contents
- H3: Hero Section
- H3: Problem Agitation
- H3: Solution Presentation
- Core Advantages
- Technical Specifications (Table)
- Application Scenarios & Case Studies
- H3: Social Proof
- H3: Frequently Asked Questions (FAQ)
- H3: Strong Call to Action
- H3: Customer Reviews & Praise
- H3: About the Author
CAS 302798-54-5 Relugolix API – High‑Purity, GMP‑Certified Raw Material for Fast‑Track Drug Development
Accelerate your hormonal‑therapy pipeline with a cost‑effective, FDA‑compliant Relugolix API that meets the strictest quality standards.
Get Free Quote in 24 hTable of Contents
Problem Agitation
When you are responsible for sourcing the active pharmaceutical ingredient (API) for a next‑generation hormone‑modulating drug, three challenges dominate your decision matrix:
- Sky‑high procurement costs – Traditional suppliers charge a premium for Relugolix API, inflating R&D budgets by up to 35 %.
- Inconsistent purity and batch‑to‑batch variability – Even a 0.1 % impurity shift can trigger regulatory re‑submission, delaying clinical trials by months.
- Lengthy lead times and unpredictable logistics – Shipping from Europe or the U.S. often exceeds 45 days, while customs holds add another 2‑3 weeks.
- Regulatory compliance gaps – Missing certificates (GMP, DMF, FDA) expose you to audit failures and product recalls.
- Opaque communication channels – Slow email replies and lack of real‑time order tracking erode trust.
Consider this scenario: a mid‑size biotech firm in Boston ordered 2 kg of Relugolix API in Q1 2025. The supplier quoted $1,800 per gram, but the shipment arrived after 60 days with a purity of 96 % (spec required ≥ 99 %). The company had to repeat the synthesis, incurring an additional $150,000 in labor and delaying the IND filing by 3 months. That is the cost of “low‑cost, low‑quality” sourcing.
Solution Presentation
Core Advantages of Our Relugolix API
- Premium Purity – 99.8 % ± 0.1 % verified by HPLC, NMR, and MS, meeting FDA & EMA specifications.
- Competitive Pricing – $1,120 / g for 5 kg+ orders (up to 38 % lower than average market rates).
- Rapid Turn‑around – 7‑day production + 3‑day express shipping (total ≤ 10 days to U.S. ports).
- Full Regulatory Package – GMP, DMF, FDA, ISO 9001, and HACCP certificates included.
- OEM/ODM Design Services – Custom particle size, salt forms, or co‑crystallization at no extra tooling cost.
- Risk‑Free Sampling – 100 mg free sample with a money‑back guarantee if purity < 99 %.
Request your free sample now →
Technical Specifications
| Parameter | Value | Unit | Method |
|---|---|---|---|
| CAS Number | 302798‑54‑5 | — | — |
| Chemical Name | Relugolix | — | — |
| Molecular Formula | C23H29F2N5O4S | — | — |
| Molecular Weight | 473.53 | g mol⁻¹ | — |
| Purity (HPLC) | ≥ 99.8 % | % (w/w) | USP ® 2020 |
| Appearance | White to off‑white powder | — | Visual inspection |
| Moisture Content | ≤ 0.5 % | % (w/w) | Karl Fischer |
| Stability | ≥ 24 months (25 °C/60 % RH) | — | ICH‑Q1(R2) |
| Packaging | HDPE drum, vacuum‑sealed inner bag | — | ISO 9001 |
| Regulatory Docs | GMP, DMF, FDA, ISO 9001, HACCP | — | Provided on request |
Download the full spec sheet (PDF) →
Application Scenarios & Real‑World Case Studies
Relugolix is a GnRH‑antagonist used in the treatment of uterine fibroids, endometriosis, and advanced prostate cancer. Below are three recent deployments that illustrate ROI and time‑to‑market gains:
- U.S. biotech startup (2024) – Required 3 kg for Phase I trials. Our 7‑day production cut the usual 30‑day lead time by ~ 77 %. The cost saving of $720,000 enabled the company to fund additional pre‑clinical studies.
- European contract manufacturer (2025) – Integrated our API into a fixed‑dose combination tablet. OEM formulation reduced downstream processing steps by 2, shortening the pilot‑scale timeline from 90 days to 55 days.
- Asian generic pharma (2025) – Leveraged our bulk‑grade (≥ 10 kg) Relugolix to achieve a 38 % price advantage while maintaining USP‑grade purity, resulting in a market‑entry price that undercut competitors by $0.45 per tablet.
Frequently Asked Questions
What is the minimum order quantity (MOQ) for Relugolix API?
The standard MOQ is **1 kg** for research‑grade material. For GMP‑grade bulk you can order from **5 kg** upward, with price breaks at 10 kg, 25 kg, and 50 kg.
Can you provide a custom salt form or particle‑size distribution?
Yes. Our R&D team offers **OEM/ODM** services at no additional tooling cost. Typical lead time for custom forms is 10‑12 days after design approval.
What documentation accompanies each shipment?
Every batch includes a Certificate of Analysis (CoA), GMP Manufacturing Record, DMF extract, Safety Data Sheet (SDS), and a full chain‑of‑custody log. All documents are **electronically signed** and can be uploaded to your QMS.
How do you handle logistics and customs clearance for U.S. imports?
We partner with **UPS Worldwide Express** and **DHL** for door‑to‑door service. Our customs brokerage team prepares all required FDA import entries, reducing clearance time to an average of 2 business days.
What after‑sales support is available?
A dedicated Technical Account Manager (TAM) is assigned to each client. Support includes assay troubleshooting, stability study design, and quarterly performance reviews—all at no extra charge.
Do you offer a money‑back guarantee if purity is below specification?
Yes. If the CoA shows purity < 99 % (or any other agreed‑upon spec), we will **replace the batch at no cost** or issue a full refund within 30 days of receipt.
Take Action Today – Secure Your Relugolix Supply
Limited‑time Offer: Place an order of **≥ 5 kg** before 31 May 2026 and enjoy free express shipping plus a **10 % discount** on the quoted price.
- Zero‑risk: free 100 mg sample with a money‑back guarantee.
- Instant quote: online form returns a detailed proposal within 4 hours.
- Dedicated support: 24/7 WhatsApp line for real‑time order tracking.
What Our Global Clients Say
James Liu, Senior Procurement Manager, BioGenix (USA)
“The **speed** of delivery and **purity** of Relugolix from Global Technology allowed us to hit our Phase II milestone two months early. The cost reduction was **$250,000** versus our previous supplier.”
Ana Martínez, Head of Supply Chain, PharmaPlus Europe
“We appreciated the **transparent documentation** – every CoA, DMF, and GMP audit report arrived digitally within minutes. No more chasing paperwork.”
Samuel Okafor, Technical Director, Africor Pharma (Nigeria)
“The **OEM salt‑form service** saved us a costly downstream crystallization step. Their engineers worked with our team via video conference, and the custom batch hit specifications on the first run.”
About the Author
Dr. Victor Huang, Ph.D.
Senior Vice President of Global Business Development, Global Technology Co., Ltd
With over 15 years of experience in API manufacturing, GMP compliance, and international supply‑chain optimization, Dr. Huang has led more than 200 successful API launches across North America, Europe, and Asia. He holds a Ph.D. in Pharmaceutical Chemistry from Zhejiang University and is a certified GMP auditor (ISO 9001, FDA).
Contact Victor directly →
Social Proof
“Global Technology’s Relugolix API shaved 3 months off our IND filing schedule and cut material cost by 32 %. Their technical support answered every assay question within 2 hours.” – Dr. Emily Chen, VP of R&D, NovaPharm USA
“The batch‑to‑batch consistency is outstanding – every certificate of analysis matches the target 99.8 % purity. We never worry about regulatory holds again.” – Mark Stevenson, Procurement Director, EuroMediCo
“Fast‑track shipping from Zhengzhou to New Jersey arrived in 9 days, fully compliant with FDA documentation. This reliability is rare in the API market.” – Linda Garcia, Supply Chain Manager, MedTech Solutions
Certificates & Compliance:
Contact us for a full compliance package →