Share This Page
Suppliers and packagers for generic pharmaceutical drug: PRASTERONE
✉ Email this page to a colleague
PRASTERONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-401-28 | 1 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 |
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-501-14 | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Prasterone (Dehydroepiandrosterone, DHEA)
Introduction
Prasterone, commonly known as Dehydroepiandrosterone (DHEA), is an endogenous steroid hormone precursor involved in the biosynthesis of androgens and estrogens. Widely used in hormone replacement therapy and cosmetic applications, its pharmaceutical formulation demands consistent sourcing from reputable suppliers to ensure quality, efficacy, and regulatory compliance. This report provides an in-depth overview of key suppliers, manufacturing landscape, and strategic considerations for procurement within the DHEA market.
Market Overview of Prasterone Suppliers
The global supply chain for prasterone involves pharmaceutical-grade chemical producers, custom synthesis companies, and specialty chemical suppliers. Major players span from multinational pharmaceutical raw material manufacturers to regional specialists serving niche therapeutic segments. Given the compound's complex synthesis pathways and regulatory scrutiny, only suppliers adhering to stringent quality standards such as cGMP (current Good Manufacturing Practice) are considered viable partners.
Major Suppliers and Manufacturers
1. Harsch Chemie GmbH & Co. KG
Harsch Chemie, based in Germany, is a recognized supplier specializing in steroid hormones and intermediates, including DHEA. The company offers pharmaceutical-grade prasterone suitable for formulators requiring consistent supply and high purity (>99%). Their products are compliant with international regulatory standards, and they serve clients across North America, Europe, and Asia.
2. Sigma-Aldrich (Merck KGaA)
A global leader in laboratory chemicals and pharmaceutical raw materials, Sigma-Aldrich supplies DHEA for research and development purposes. While primarily serving research institutions, they offer pharmaceutical-grade batches suitable for early-stage clinical applications. Their extensive distribution network ensures product availability worldwide.
3. Toronto Research Chemicals (TRC)
TRC provides high-purity DHEA for laboratory and pharmaceutical applications. They emphasize stringent quality control, offering products with Certificates of Analysis (CoA) that meet specifications for potency, purity, and stability. TRC caters to R&D, API manufacturing, and formulation development sectors.
4. BOC Sciences
Specializing in custom synthesis and supply of steroid hormones, BOC Sciences supplies pharmaceutical-grade DHEA to pharmaceutical companies and contract manufacturers. They offer comprehensive services, including analytical testing and regulatory support.
5. Tocris Bioscience
Tocris, part of Bio-Techne, supplies research-grade DHEA, emphasizing strict quality controls. They focus primarily on research and development sectors but maintain partnerships allowing transfer into clinical-grade production upon demand.
Emerging and Regional Players
Regional chemical manufacturers in India, China, and Eastern Europe have started producing prasterone derivatives owing to increasing demand. However, procurement from these suppliers requires rigorous quality verification and compliance with international standards to avoid regulatory hurdles.
Regulatory and Quality Considerations
Sourcing from reputable suppliers is essential to meet pharmacopoeial standards such as the USP, EP, or JP monographs. Suppliers should possess relevant certifications, including:
- cGMP compliance
- ISO certifications (e.g., ISO 9001, ISO 13485)
- WHO-GMP accreditation
Additionally, suppliers should provide comprehensive documentation, including CoAs, Certificates of Analysis, and stability data, which are critical during regulatory submissions and quality assurance processes.
Strategic Procurement Insights
- Assessment of Supplier Capabilities: Verify manufacturing capacity, quality control protocols, and past compliance history.
- Supply Chain Security: Establish multiple supplier relationships to mitigate risks associated with supply disruptions.
- Regulatory Alignment: Ensure suppliers' products meet the regulatory jurisdictions where the drug will be marketed.
- Pricing and Lead Time: Negotiate terms considering batch sizes, pricing models, and lead times aligned with production schedules.
Challenges and Considerations
- Regulatory Scrutiny: Due to DHEA's hormonal activity, sourcing from non-compliant suppliers may lead to regulatory issues.
- Quality Variability: Variations in purity and potency across suppliers necessitate rigorous qualification and testing.
- Market Dynamics: The rise in demand for DHEA, driven by aging populations and cosmetic applications, may impact supply availability and pricing.
Conclusion
The procurement of prasterone requires diligent supplier vetting to ensure high quality, regulatory compliance, and reliable supply. Leading global suppliers such as Harsch Chemie, Sigma-Aldrich, and BOC Sciences stand out as primary sources for pharmaceutical-grade DHEA. Strategic partnership with these suppliers can support long-term manufacturing stability, quality assurance, and regulatory success.
Key Takeaways
- Reputable Manufacturers: Major global suppliers, including Harsch Chemie, Sigma-Aldrich, and BOC Sciences, dominate the prasterone supply chain.
- Quality Assurance: Ensure suppliers hold necessary certifications and provide comprehensive documentation to meet international standards.
- Regulatory Compliance: Source from suppliers compliant with cGMP and other pharmacopoeial requirements to avoid regulatory hurdles.
- Supply Chain Strategy: Diversify supplier base to reduce risks of shortages or delays; develop long-term relationships for stability.
- Market Trends: Stay informed on regulatory changes and market demand dynamics to adapt procurement strategies proactively.
FAQs
1. What are the primary uses of prasterone in pharmaceuticals?
Prasterone is mainly used in hormone replacement therapies, treatment of adrenal insufficiency, and as a component in anti-aging and cosmetic products due to its role as a steroid hormone precursor.
2. How can I verify the quality of prasterone from suppliers?
Verify that the supplier provides Certificates of Analysis, complies with pharmacopeial standards (USP, EP), and maintains certifications such as cGMP and ISO. Conduct independent testing when necessary.
3. Are there regional differences in the availability of prasterone?
Yes. Suppliers in Europe and North America generally adhere to stricter regulatory standards, providing higher assurance of quality. Asian suppliers may offer cost advantages but require careful validation to ensure compliance.
4. What are the regulatory challenges involved in sourcing DHEA?
DHEA is classified as a controlled substance or hormone precursor in many jurisdictions, which complicates import, export, and registration processes. Suppliers must comply with local regulations, and proper documentation is essential.
5. Can prasterone be sourced for research purposes only?
Yes. Many suppliers offer research-grade DHEA, which may have different purity standards and regulatory requirements compared to pharmaceutical-grade material intended for commercial manufacturing.
Sources
[1] European Pharmaceutical Review. "DHEA: A Comprehensive Review of Use and Supply." 2022.
[2] Sigma-Aldrich Product Catalog. "DHEA (Dehydroepiandrosterone)." 2023.
[3] BOC Sciences. "Steroid Hormones and Intermediates." 2023.
[4] World Health Organization. "Global Standards for Pharmaceutical Substances." 2022.
[5] U.S. Pharmacopeia (USP). "Dehydroepiandrosterone Monograph." 2023.
More… ↓
