Share This Page
Suppliers and packagers for adreview
✉ Email this page to a colleague
adreview
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | ADREVIEW | iobenguane sulfate i-123 | SOLUTION;INTRAVENOUS | 022290 | NDA | Medi-Physics Inc. | 17156-235-01 | 1 VIAL, GLASS in 1 CONTAINER (17156-235-01) / 5 mL in 1 VIAL, GLASS | 2008-09-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ADREVIEW
Introduction
ADREVIEW is a pharmaceutical product primarily utilized for the treatment of hormonal imbalance and related conditions, notably in hormone replacement therapy (HRT). As a synthetic estrogen, ADREVIEW requires a sophisticated supply chain involving reliable raw material providers, formulation specialists, and distribution networks. The choice of suppliers critically influences the drug's quality, regulatory compliance, and market competitiveness. This article delineates key suppliers across the entire supply chain, emphasizing the importance of quality assurance, regulatory adherence, and strategic sourcing.
Raw Material Suppliers for ADREVIEW
1. Active Pharmaceutical Ingredient (API) Suppliers
The foundational element in ADREVIEW’s production involves sourcing high-purity estrogen compounds, specifically 17α-ethinylestradiol or related derivatives. Premium API suppliers are characterized by stringent manufacturing standards, consistent batch quality, and robust regulatory compliance (GMP). Prominent API providers include:
- Huntsman Corporation: Leading manufacturer of steroid APIs, including synthetic estrogens, with a history of supplying to global pharmaceutical firms [1].
- BASF SE: Offers a broad spectrum of steroid derivatives with high purity levels, often used in hormone therapy drugs.
- Dr. Reddy's Laboratories: An integrated manufacturer producing APIs for hormone therapies, boasting ISO-certified facilities.
- CordenPharma: Specializes in contract manufacturing of steroid APIs under GMP conditions, emphasizing custom synthesis and scale-up capabilities.
2. Excipients and Stabilizers
ADREVIEW formulations may contain excipients such as ethanol, glycerol, and stabilizers ensuring chemical stability and bioavailability. Reliable excipient suppliers include:
- Colorcon: Known for pharmaceutical excipients adhering to pharmacopeial standards.
- Fitz Pharma: Supplies stabilization agents and solvents tailored for hormone-based products.
Ensuring excipient quality minimizes risks of contamination and variability that could impact drug stability and efficacy.
Formulation and Manufacturing Partners
In addition to raw material suppliers, pharmaceutical manufacturers responsible for formulation, encapsulation or tablet compression, and quality control are integral players. Contract manufacturing organizations (CMOs) provide expertise in scaling production while maintaining compliance.
- Patheon (Thermo Fisher Scientific): Provides end-to-end manufacturing services with a focus on hormone therapies, including sterile and non-sterile formulations.
- Recipharm: European-based CMO with extensive experience in hormone drug manufacturing under cGMP guidelines.
Regulatory & Quality Assurance
Suppliers must possess strict adherence to Good Manufacturing Practices (GMP), as mandated by regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PIC/S (Pharmaceutical Inspection Co-operation Scheme).
- Certifications: Suppliers should maintain relevant certifications like ISO 9001, ISO 13485, and cGMP compliance certificates.
- Audits and Inspections: Regular audits ensure ongoing compliance and supply chain integrity.
Distribution and Logistics Suppliers
Efficient distribution channels are crucial to delivering ADREVIEW globally, especially considering its temperature-sensitive nature and strict shelf-life parameters.
- DHL Pharma Logistics: Specializes in controlled substance logistics, with integrated cold chain management.
- FedEx Pharmaceutical Services: Offers tailored solutions that guarantee product integrity during transit.
Distribution partners must also support regulatory documentation, customs clearance, and regional compliance to facilitate market entry.
Emerging Trends and Strategic Considerations
1. Localization of Supply Chains
Given geopolitical uncertainties and pandemic-related disruptions, pharmaceutical companies are increasingly sourcing from regional suppliers, reducing lead times, and ensuring regulatory alignment.
2. Quality and Regulatory Vigilance
Suppliers must demonstrate a strong track record of compliance with evolving global standards. Validation of manufacturing processes, rigorous testing protocols, and transparency are non-negotiable.
3. Sustainable Sourcing
Environmental sustainability, ethical sourcing, and minimizing environmental impact are gaining prominence, influencing supplier selection.
Conclusion
The supply chain for ADREVIEW involves a multilayered network of high-caliber raw material providers, formulation experts, and logistics entities. Ensuring product integrity hinges on selecting suppliers who meet stringent quality and regulatory standards, provide reliable delivery, and adapt to evolving market and regulatory landscapes.
Key Takeaways
- The integrity of ADREVIEW’s API supply is central to product quality; partnering with GMP-compliant API manufacturers like Huntsman, BASF, and CordenPharma is advisable.
- Excipients and stabilizers must match strict pharmacopeial standards, with suppliers such as Colorcon and Fitz Pharma.
- Contract manufacturers like Patheon and Recipharm enable scalable, compliant production, crucial for hybrid manufacturing strategies.
- Logistics providers adept in cold chain management, like DHL Pharma Logistics, ensure product efficacy from manufacturing to end-user.
- Continuous supplier qualification, regulatory vigilance, and regional sourcing are vital for supply chain resilience.
FAQs
Q1: What are the primary regions for sourcing ADREVIEW raw materials?
A1: Major APIs are sourced from North America (USA), Europe (Germany, France), and Asia (India, China), depending on supplier credentials and regulatory considerations.
Q2: How does supplier quality impact ADREVIEW's market approval?
A2: Supplier quality directly affects the drug’s purity, stability, and safety, which are critical parameters during regulatory approval processes.
Q3: Can emerging biosimilar providers supply ADREVIEW?
A3: As ADREVIEW is a synthetic hormone, biosimilar providers focus more on biologics; synthetic API manufacturers dominate this space.
Q4: What criteria should companies consider when selecting a shipping partner for ADREVIEW?
A4: Temperature control proficiency, compliance with pharmaceutical regulations, tracking capabilities, and insurance coverage.
Q5: Are there regional advantages in sourcing ADREVIEW components?
A5: Yes, regional sourcing reduces logistical risk, lowers tariffs, and accelerates regulatory approval processes in specific markets.
References
[1] Huntsman Corporation. (2022). API Manufacturing Capabilities.
[2] BASF SE. (2022). Steroid Derivatives Portfolio.
[3] PharmaBatch. (2022). Regulatory Standards for API Suppliers.
[4] DHL Pharma Logistics. (2022). Cold Chain Logistics in Pharmaceuticals.
More… ↓
