Oncology APIs
Premium Active Pharmaceutical Ingredients for Cancer Treatment
About Oncology APIs
Holiness Pharmaceutical is a leading manufacturer and exporter of high-quality Oncology Active Pharmaceutical Ingredients (APIs) designed to support the development of life-saving cancer therapies. Our oncology portfolio includes chemotherapy agents, targeted therapy compounds, and immunotherapy ingredients manufactured under strict WHO-GMP guidelines.
Key Features
- WHO-GMP and ISO certified manufacturing facilities
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Advanced synthesis technology for complex molecules
- Stringent quality control and analytical testing
- Complete documentation and regulatory support
- Global supply chain with reliable delivery
- Custom synthesis and development services
- Stable supply for clinical and commercial use
Application Areas
Chemotherapy Agents
Traditional cytotoxic drugs that target rapidly dividing cancer cells
Targeted Therapy
Precision medicines targeting specific cancer pathways and mutations
Immunotherapy Compounds
Ingredients supporting immune system-based cancer treatments
Hormonal Therapy
APIs for hormone-dependent cancers treatment
Quality Assurance
Every batch of our oncology APIs undergoes rigorous testing including HPLC, GC, spectroscopy, and microbial testing to ensure the highest purity and safety standards. Our dedicated quality control team ensures compliance with international regulatory requirements.
Our Oncology APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Bortezomib API | 179324-69-7 | IP | API Powder | View Product |
Methotrexate API | 59-05-2 | BP/EP/USP | API Powder | View Product |
Frequently Asked Questions
What are Oncology APIs?
Oncology APIs (Active Pharmaceutical Ingredients) are the biologically active components used in the manufacturing of cancer treatment medications. These include chemotherapy drugs, targeted therapy agents, and immunotherapy compounds that work by various mechanisms to inhibit cancer cell growth, induce apoptosis, or enhance the immune system's ability to fight cancer.
What quality standards do your Oncology APIs meet?
Our Oncology APIs are manufactured in WHO-GMP certified facilities and comply with international pharmacopeial standards including IP (Indian Pharmacopoeia), BP (British Pharmacopoeia), USP (United States Pharmacopeia), and EP (European Pharmacopoeia). Each batch undergoes comprehensive quality testing including HPLC, spectroscopy, and purity analysis.
Which oncology APIs does Holiness Pharmaceutical manufacture?
We manufacture a comprehensive range of oncology APIs including Bortezomib, Capecitabine, Cisplatin, Cyclophosphamide, Olaparib, and Oxaliplatin. Our portfolio covers various therapeutic classes including alkylating agents, antimetabolites, platinum compounds, and targeted therapy agents.
Do you provide regulatory support for Oncology APIs?
Yes, we provide complete regulatory documentation including Certificate of Analysis (CoA), Drug Master Files (DMF), stability data, and impurity profiles. Our regulatory affairs team supports customers with documentation required for product registration in various countries.
What is the minimum order quantity for Oncology APIs?
Minimum order quantities vary depending on the specific API and customer requirements. We offer flexible ordering options for both commercial-scale manufacturing and clinical trial supplies. Please contact our sales team for specific MOQ information and custom synthesis options.
How do you ensure the safety and purity of cytotoxic APIs?
We maintain dedicated manufacturing facilities with specialized containment systems for cytotoxic compounds. Our safety protocols include operator training, environmental monitoring, cross-contamination prevention, and rigorous cleaning validation. All products meet stringent purity specifications with documented impurity profiles.
Can you develop custom Oncology APIs?
Yes, we offer custom synthesis and process development services for oncology APIs. Our R&D team can develop scalable manufacturing processes from lab to commercial scale, including method development, optimization, and technology transfer.
What countries do you export Oncology APIs to?
We export our oncology APIs globally to regulated and semi-regulated markets including countries in Asia, Africa, Latin America, Middle East, and CIS regions. Our logistics team ensures compliant packaging, documentation, and timely delivery to international customers.