Share This Page
Suppliers and packagers for HYDROCORTISONE
✉ Email this page to a colleague
HYDROCORTISONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 087795 | ANDA | Actavis Pharma, Inc. | 0472-0321-26 | 1 TUBE in 1 CARTON (0472-0321-26) / 28.4 g in 1 TUBE | 2002-01-03 |
| Actavis Mid Atlantic | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 087795 | ANDA | RedPharm Drug | 67296-0833-1 | 30 g in 1 TUBE (67296-0833-1) | 2002-01-03 |
| Actavis Mid Atlantic | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 087795 | ANDA | DIRECT RX | 72189-209-28 | 28.4 g in 1 TUBE (72189-209-28) | 2021-05-17 |
| Actavis Mid Atlantic | HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 089682 | ANDA | Actavis Pharma, Inc. | 0472-0337-20 | 1 TUBE in 1 CARTON (0472-0337-20) / 20 g in 1 TUBE | 2002-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: HYDROCORTISONE
Introduction
Hydrocortisone, a synthetic corticosteroid, is widely used for its anti-inflammatory, immunosuppressive, and metabolic effects to treat conditions like adrenal insufficiency, allergies, and inflammatory disorders. As a critical component in pharmaceutical formulations, the sourcing of hydrocortisone requires a comprehensive understanding of global suppliers, manufacturing standards, and regulatory compliance. This article examines the key suppliers of hydrocortisone, their manufacturing capabilities, regulatory considerations, and the implications for pharmaceutical companies seeking reliable sourcing options.
Global Suppliers of Hydrocortisone
1. Major API Manufacturers
The backbone of hydrocortisone supply chains comprises API (Active Pharmaceutical Ingredient) manufacturers, predominantly based in India, China, and Europe. These regions host companies that produce both synthetic and plant-derived forms of hydrocortisone, adhering to international quality standards.
-
India: The Indian pharmaceutical sector is a dominant player in hydrocortisone supply, led by companies such as Wockhardt, Lupin, and Cipla. These firms operate extensive manufacturing facilities compliant with WHO-GMP standards, ensuring high-grade APIs suitable for global distribution.
-
China: Chinese manufacturers like North China Pharmaceutical Group (NCPC) and Shandong Taihe Pharmaceutical Co., Ltd. supply significant volumes of hydrocortisone APIs. These producers benefit from cost advantages but necessitate careful quality assessment due to varying regulatory oversight.
-
Europe: European API producers such as Sandoz (Novartis), Fresenius Kabi, and Bachem focus on high-quality APIs. They tend to serve markets with stringent regulatory requirements, offering products with comprehensive pharmacopoeial compliance.
2. Contract Manufacturing and OEM Suppliers
Several companies specialize in custom synthesis and contract manufacturing, providing hydrocortisone APIs tailored to client specifications:
- HETERA PHARMA (India): Offers hydrocortisone in multiple grades with ISO and GMP certification.
- Hubei Hongyuan Medical Material Co., Ltd. (China): Focuses on bulk hydrocortisone production with export capabilities.
- Shanghai Epochem Pharmaceutical (China): Provides high-purity hydrocortisone APIs for pharmaceutical companies worldwide.
3. Biosynthetic and Plant-Derived Sources
While most hydrocortisone APIs are synthetic, some suppliers explore plant-derived precursors or biosynthetic pathways to enhance sustainability and reduce environmental impact. These emerging sources are still under validation but show potential for future supply diversification.
Regulatory and Quality Considerations
Sourcing hydrocortisone demands rigorous quality assurance, as APIs must meet pharmacopeial standards — USP, EP, or JP. Suppliers are typically accredited under international regulatory frameworks:
- GMP Compliance: Most reputable suppliers maintain Good Manufacturing Practice (GMP) certifications, vital for ensuring consistent quality and facilitating market approval.
- Regulatory Approvals: APIs intended for global markets often require authorization from agencies like the FDA, EMA, or TGA, especially for high-value and patent-expired drugs.
Pharmaceutical companies must verify supplier certifications, conduct batch testing, and review supplier audit reports before procurement. Furthermore, the geopolitical stability and export controls in supplier regions influence sourcing reliability.
Supply Chain Dynamics and Challenges
The supply of hydrocortisone faces several industry-specific challenges:
- Raw Material Constraints: Fluctuations in raw material availability—particularly steroids derived from plant sources—can disrupt production.
- Regulatory Scrutiny: Increasing regulations on steroid APIs may lead to supply bottlenecks, especially from regions with evolving compliance standards.
- Manufacturing Capacity: Surges in demand, especially during pandemics or for generic formulations, strain manufacturing capacities.
- Pricing and Cost: Cost competitiveness varies significantly between regions, with China and India offering lower-cost APIs but requiring stringent quality control.
Strategic partnerships and multiple sourcing options are critical for mitigating supply disruptions. Companies often diversify supplier bases across geographies, balancing cost, quality, and regulatory compliance.
Major Players in the Hydrocortisone Market
| Company | Location | Capacity | Certification | Notable Attributes |
|---|---|---|---|---|
| Wockhardt | India | Large-scale | WHO-GMP, USDMF | Cost-effective, reliable |
| Lupin | India | Extensive | ISO, GMP | Broad API portfolio |
| North China Pharmaceutical | China | Significant | GMP | Competitive supply |
| Sandoz (Novartis) | Europe | High-quality | EMA-approved | Focus on stringent standards |
| Bachem | Europe | Specialized | GMP, USP | Focus on high-purity APIs |
Future Outlook
The hydrocortisone API market is poised for moderate growth driven by the continuing demand for generic corticosteroids. Innovations in biosynthesis and sustainable production methodologies may reduce dependencies on traditional chemical synthesis. Additionally, evolving regulatory landscapes will require suppliers to invest in quality and compliance, favoring established players with proven track records.
Emerging markets in Southeast Asia and Africa represent opportunities for expanding supply chains, provided suppliers meet international standards. The shift towards lower-cost, high-quality APIs will likely intensify competition among existing suppliers and encourage new entrants.
Key Takeaways
- Diversify sourcing: Relying on multiple suppliers across different regions reduces supply risks and ensures regulatory compliance.
- Prioritize quality assurance: Only engage suppliers with proven GMP certifications and transparent quality control processes.
- Monitor regulatory developments: Stay informed about changing international regulations impacting steroid API manufacturing and import/export controls.
- Invest in supplier relationship management: Long-term partnerships with reputable suppliers can secure priority in supply allocations and support compliance.
- Explore emerging sources: Biosynthetic and plant-based APIs represent sustainable alternatives that could reshape the supply landscape.
FAQs
1. Who are the leading global suppliers of hydrocortisone API?
The leading suppliers include Wockhardt, Lupin, North China Pharmaceutical, Sandoz (Novartis), and Bachem, operating primarily across India, China, and Europe.
2. What regulatory standards must hydrocortisone suppliers meet?
Suppliers should comply with GMP, and their APIs should meet pharmacopeial standards such as USP, EP, or JP. Certifications like ISO, USDMF, and EMA approval further validate quality.
3. How does geopolitical stability affect hydrocortisone supply chains?
Geopolitical factors influence export policies, trade restrictions, and raw material availability, which can disrupt supply. Diversification helps mitigate these risks.
4. What are the sustainability considerations in sourcing hydrocortisone?
Emerging biosynthetic methods and plant-derived precursors offer more sustainable options, reducing environmental impact compared to traditional chemical synthesis.
5. How can pharmaceutical companies secure reliable hydrocortisone supply?
By establishing strategic supplier relationships, conducting rigorous audits, verifying certifications, and maintaining diverse sourcing channels, companies can ensure consistent API availability.
Sources
[1] Pharmaceutical Technology. "The global corticosteroids API market."
[2] WHO. "Good Manufacturing Practices (GMP) Guidelines."
[3] U.S. Pharmacopeia. "Hydrocortisone Monograph."
[4] MarketWatch. "Hydrocortisone API Market Forecast."
[5] European Medicines Agency. "Regulatory guidelines for steroid APIs."
More… ↓
