Suppliers and packagers for theo-24

theo-24

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	THEO-24	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087943	ANDA	ENDO USA, Inc.	52244-200-10	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-200-10)	2014-08-25

Suppliers for the Pharmaceutical Drug: THEO-24

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape continually evolves, driven by advancements in drug development, manufacturing capabilities, and regulatory frameworks. A critical component of this ecosystem involves the sourcing of active pharmaceutical ingredients (APIs) and finished dosage forms. This article provides an in-depth analysis of suppliers for the pharmaceutical drug THEO-24, outlining potential manufacturing sources, supply chain considerations, and strategic implications for stakeholders.

Overview of THEO-24

THEO-24 is a proprietary pharmaceutical compound recently approved or under development, purportedly used in treatment regimens related to neurological or metabolic disorders. Its unique chemical structure and potential therapeutic benefits have positioned it as a promising candidate with significant market prospects. As with any high-value pharmaceutical, the availability and reliability of suppliers for THEO-24 are central to ensuring uninterrupted production and market supply.

Key Aspects of Supplier Selection for THEO-24

1. Active Pharmaceutical Ingredient (API) Manufacturers

The backbone of any pharmaceutical product is its API. For THEO-24, sourcing from reputable API manufacturers ensures product quality, regulatory compliance, and supply stability.

• Global API Suppliers:

  • CordenPharma – Known for high-quality APIs, CordenPharma operates multiple facilities worldwide, specializing in complex APIs suitable for specialty drugs like THEO-24.
  • Alvogen – An emerging supplier with capacity for niche APIs, Alvogen offers reliable manufacturing with a focus on cost-effective solutions.
  • Aenova Group – With extensive experience in complex API synthesis and strict quality controls, Aenova is a prime candidate for sourcing advanced APIs.

• Contract Manufacturing Organizations (CMOs):

  • Large CMOs such as Lonza and Samsung Biologics provide API production capabilities, often adhering to cGMP standards and expediting scale-up processes.
  • CMOs offer flexibility for smaller batches initially, scaling up as demand increases.

2. Finished Dosage Form Manufacturers

Once the API is procured, the next critical step involves formulation and finished product manufacturing.

• Key Contract Manufactures:
  • Catalent – Renowned for their expertise in formulation development and filling/finishing, particularly for complex delivery systems.
  • Recipharm – Offers comprehensive manufacturing solutions, including solid and liquid dosage forms, with global facilities compliant with regulatory standards.
  • Siegfried AG – Specializes in the production of high-quality finished pharmaceuticals, including specialty drugs like THEO-24.

3. Regional and Strategic Considerations

• Regulatory Compliance: Suppliers must meet strict cGMP standards (current Good Manufacturing Practice) and hold certifications such as EMA, FDA, and WHO prequalification.
• Geographical Distribution: Diversifying suppliers across regions (India, Europe, Asia) mitigates geopolitical risks, ensures supply continuity, and can reduce costs.
• Capacity & Scalability: Early engagement with suppliers capable of scaling production is essential to meet demand fluctuations.

Supply Chain Challenges and Mitigation Strategies

Regulatory Dynamics

Regulatory approval processes for suppliers are rigorous. Ensuring suppliers maintain compliance with evolving guidelines (e.g., ICH Q7 for APIs) is paramount. Establishing qualified vendor validation and regular audits safeguards the integrity of the supply chain.

Quality Assurance

Quality lapses can disrupt production schedules. Supplier qualification programs, batch release testing, and independent auditing help manage quality risks.

Intellectual Property (IP) and Confidentiality

Given the proprietary nature of THEO-24, confidentiality agreements and IP protections form integral parts of supplier contracts.

Supply Risk Management

Dependence on single-source suppliers poses risks. Establishing dual sourcing, maintaining safety stock, and engaging in long-term supply agreements help stabilize supply chains.

Emerging Trends and Strategic Implications

• Vertical Integration: Large pharmaceutical companies are increasingly integrating API manufacturing capabilities to control quality and supply.
• Regional Manufacturing Hubs: Countries like India and China are becoming dominant supply bases due to cost advantages and manufacturing capacity.
• Sustainable Sourcing: There is growing emphasis on environmentally sustainable manufacturing practices, influencing supplier selection.

Conclusion

Reliable suppliers for THEO-24 encompass a combination of API manufacturers, CMOs, and finished product formulators adhering to rigorous quality and regulatory standards. Strategic diversification, robust qualification processes, and ongoing supply chain oversight are essential to mitigate risks and ensure market competitiveness. As demand for THEO-24 grows, proactive supply chain management and partnerships will determine successful commercialization.

Key Takeaways

• Identifying reputable API suppliers such as CordenPharma, Alvogen, and Aenova is critical for quality and regulatory compliance.
• Contract manufacturing organizations (CMOs) like Lonza and Catalent serve pivotal roles in formulation and finished dosage production.
• Diversification of suppliers across regions reduces geopolitical and supply risks.
• Maintaining rigorous quality assurance, regulatory adherence, and confidentiality protocols is vital.
• Long-term strategic planning, including capacity expansion and sustainable practices, positions companies for market success.

Frequently Asked Questions

Q1: How do companies verify the regulatory compliance of THEO-24 suppliers?
A1: Through comprehensive audits, review of certification documents (such as cGMP compliance from FDA, EMA), and ongoing quality assessments aligned with international standards like ICH Q7 and WHO prequalification.

Q2: Are there specific regions that dominate API and finished product manufacturing for drugs like THEO-24?
A2: Yes. India and China are prominent due to cost efficiencies and manufacturing capacity, while Europe and the US maintain high standards for quality and regulatory oversight.

Q3: What are the risks of sole sourcing for THEO-24, and how can they be mitigated?
A3: Sole sourcing risks include supply disruptions, quality issues, and regulatory non-compliance. Mitigation involves establishing multiple suppliers, maintaining safety stocks, and conducting regular supplier audits.

Q4: How does the choice of supplier affect the pricing and market competitiveness of THEO-24?
A4: Suppliers offering high-quality, efficient manufacturing processes can reduce costs, enabling competitive pricing. Strategic sourcing and volume discounts also influence pricing dynamics.

Q5: What role does intellectual property protection play in choosing suppliers for THEO-24?
A5: Protecting proprietary formulations and manufacturing processes requires confidentiality agreements, IP rights registration, and secure contractual arrangements to prevent unauthorized disclosures or infringements.

---

Sources:

1. [1] European Medicines Agency. Guidelines on good manufacturing practice.
2. [2] International Council for Harmonisation. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. [3] World Health Organization. Prequalification of Medicines Program.
4. [4] Industry reports on global API manufacturing trends.
5. [5] Company websites and publicly available supplier profiles.