Relugolix API - High Purity Active Ingredient for Uterine Fibroids and Prostate Cancer.

Relugolix (CAS: 737789-87-6) is a high-purity, innovative Active Pharmaceutical Ingredient (API) belonging to the class of oral gonadotropin-releasing hormone (GnRH) receptor antagonists. It is therapeutically used for the treatment of advanced prostate cancer and uterine fibroids by rapidly suppressing sex hormone levels. Manufactured by Hefei Lifeon Pharmaceutical under strict cGMP conditions, our Relugolix API guarantees high chiral purity, low impurity profiles, and excellent stability, supporting the development of advanced therapies in oncology and gynecology.

Founded in 2002, Hefei Lifeon Pharmaceutical Co., Ltd. was successfully listed on the main board of Shenzhen Stock Exchange in December 2020 (stock code: 003020). Now it has six pharmaceutical industrial enterprises and one chain pharmacy. It is an innovative pharmaceutical enterprise integrating drug R&D, manufacturing and commercialization, and its products involve cardiovascular, central nervous system, digestive system, topical skin medicine and ophthalmology. It won the title of "China Pharmaceutical Industry's Most Valuable Enterprise" twice, and was selected as "China Chemical Pharmaceutical Industry's Top 100 Enterprises with Comprehensive Strength" for eight consecutive years.
It has been committed to the development and industrialization of osmotic pump technology for a long history. Lifeon’s internationally pioneering formulation technology of insoluble single-layer core osmotic pump won the first prize of Anhui Science and Technology Award. Till now, Its listed products and the industrialization ability are in the leading position in China.
At the same time, in order to build a differentiated competitive advantage, the company has laid out moat products with higher policies and regulations limitations:
Psychotropic drugs.
Lifeon Pharma is one of the few designated manufacturers of psychotropic drugs and narcotic drugs in China.
Modern Chinese Tradition Medicine
Lifeon Pharma inherits modern Chinese medicine with clear innovative components and clear mechanism in the field of Chinese medicine.
High-end long-acting complex injections
Lifeon Pharma actively explores the field of high-end long-acting complex injections.
Hefei Lifeon Pharma has formed a product pipeline with distinctive characteristics and strong market competitiveness.
Hefei Lifeon Pharma has five industrial bases, including its own factory, Chengzhi Bio, Dayu Pharmaceutical, Jiufang Pharmaceutical and Noratec Pharmaceutical. The company has established 33 GMP production lines, including tablets, granules, capsules, ointments, gels, APIs, oral solutions, and traditional Chinese medicine extraction. Among them, the osmotic pump workshop can achieve an annual output of 1.4 billion tablets.
In the future, Hefei Lifeon Pharma will continue to give full play to the advantages of osmotic pump technology platform, refined anti-psychotic and modern Chinese medicine, intensively cultivate and create the differentiated advantage of "specialization and novelty", provide high-quality medical products and services, and make greater contributions to healthy China.

Our innovation is driven by a strategic focus on attracting and nurturing top talent.

• Introduction:  We recruit top-tier domestic and international experts in fields like drug delivery technology, monoclonal antibodies, and chemical synthesis.

• Cultivation:  We implement structured mentorship and training programs to foster innovation and career growth within our R&D teams.

• Collaboration:  We maintain long-term partnerships with external domain experts to integrate advanced intellectual resources directly into our projects.

Frequently Asked Questions (FAQs)

Q1: What is Lifeon Pharma’s core competitive advantage?

A: Lifeon specializes in osmotic pump controlled-release technology, with internationally leading expertise in single-layer core formulations. We are one of China’s largest manufacturers of osmotic pump tablets, with an annual capacity of 1.4 billion tablets. Our product portfolio spans cardiovascular, CNS, diabetes, dermatology, and oncology, supported by 33 GMP production lines and two advanced API manufacturing sites.

Q2: Are your manufacturing facilities compliant with international standards?

A: Yes. Our facilities are fully cGMP-compliant, and we have passed multiple U.S. FDA audits (e.g., for DMSA in November 2024). We also hold certifications such as National High-Tech Enterprise and Anhui Province Pharmaceutical Quality Award, and we operate in accordance with ISO quality management systems.

Q3: What product documentation can you provide?

A: We provide comprehensive support documents including:

Certificate of Analysis (CoA)

GMP Compliance Certificate

Stability Study Data

Process Validation Reports

Material Safety Data Sheet (MSDS)
Customized documentation can be prepared upon request.

Q4: Do you offer custom synthesis or contract manufacturing services?

A: Yes. We offer custom synthesis of APIs and intermediates, and contract manufacturing for both APIs and finished dosage forms. Our strong R&D team and flexible production lines allow us to support projects from development to commercial scale.

Q5: What is your minimum order quantity (MOQ)?

A: MOQ is negotiable depending on the product and order frequency. We are flexible to accommodate both small-scale development batches and large commercial volumes.

Q6: How do you ensure supply chain reliability?

A: We have a robust dual-site production strategy with two dedicated API facilities. Our vertically integrated supply chain—from raw materials to finished products—ensures consistent supply. We also maintain long-term partnerships with reliable logistics providers to guarantee on-time delivery.

Q7: What is your typical lead time?

A: For commercial products in stock, lead time is generally 2–4 weeks. For custom projects or new synthesis, lead times will be confirmed based on project scope.

Q8: Which markets do you currently serve?

A: We supply APIs and finished products to domestic Chinese markets and have growing exports to Asia, Latin America, the Middle East, and Europe. Our products are well-positioned for both generic and branded drug markets.

Q9: Can you supply products in accordance with USP/EP/ChP standards?

A: Yes. Our products can be manufactured and released to meet USP, EP, ChP, or customer-specific standards. Quality and compliance are tailored to target market requirements.

Q10: How does Lifeon support customers technically?

A: We offer:

Technical data packages

Regulatory support for drug master files (DMFs)

Formulation development assistance

Ongoing process optimization support Our team includes PhD-level scientists and experienced engineers ready to collaborate.