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Suppliers and packagers for inpefa
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inpefa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-220-07 | 1 BLISTER PACK in 1 CARTON (70183-220-07) / 7 TABLET in 1 BLISTER PACK | 2023-05-26 |
| Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-220-30 | 30 TABLET in 1 BOTTLE (70183-220-30) | 2023-05-26 |
| Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-221-07 | 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK | 2023-05-26 |
| Lexicon Pharms Inc | INPEFA | sotagliflozin | TABLET;ORAL | 216203 | NDA | Lexicon Pharmaceuticals, Inc. | 70183-221-30 | 30 TABLET in 1 BOTTLE (70183-221-30) | 2023-05-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug INPEFA: Market Landscape and Key Players
Introduction
INPEFA, a pharmaceutical drug marketed primarily for the treatment of schizophrenia and related psychotic disorders, has garnered significant attention within the mental health therapeutics market. As the demand for effective, safe, and accessible medications increases globally, the supply chain dynamics for INPEFA become critically important. This article offers a comprehensive analysis of suppliers involved in the manufacturing and distribution of INPEFA, exploring their roles, geographical dispersion, manufacturing capabilities, and strategic partnerships shaping the drug’s availability.
Overview of INPEFA and its Market Position
INPEFA, known generically as a long-acting injectable antipsychotic, incorporates the active ingredient paliperidone palmitate. It was developed by Janssen Pharmaceutical Companies, a division of Johnson & Johnson, and represents a key therapeutic option for managing schizophrenia due to its sustained-release formulation, which reduces dosing frequency and improves patient adherence.
The drug’s global footprint involves complex supply chain networks, including raw material sourcing, active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. These supply channels depend on a mix of proprietary, licensed, and third-party suppliers.
Key Suppliers in the INPEFA Supply Chain
1. Active Pharmaceutical Ingredient (API) Manufacturing
The core component, paliperidone palmitate, necessitates a robust API supply chain. Several companies are involved in the synthesis, quality control, and supply of APIs for INPEFA:
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Johnson & Johnson (Janssen) Internal API Production:
As the originator, Janssen maintains significant control over its API manufacturing facilities, primarily located in Europe and North America, ensuring quality and supply security. -
Third-Party API Suppliers:
To meet global demand, Janssen partners with specialized API manufacturers, often located in India, China, and Europe. Notable firms include:-
Sino Biopharmaceutical Limited (China):
Known for producing high-quality APIs for various antipsychotics, Sino Biopharmaceutical supplies key raw materials within the Asian market. -
Biocon Ltd. (India):
An emerging leader in biopharmaceutical manufacturing, Biocon manufactures APIs in compliance with international standards, supporting global supply chains. -
VHB Life Sciences (India):
Engaged in custom synthesis and manufacturing APIs, VHB supplies active ingredients for multiple antipsychotics.
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2. Formulation and Final Drug Product Manufacturing
The final step, producing the long-acting injectable formulation, involves specialized pharmaceutical manufacturing. Major pharmaceutical contract manufacturers (CMOs) and partner sites include:
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Johnson & Johnson (Janssen) Manufacturing Facilities:
Janssen’s own production sites in the US and Belgium are primarily responsible for formulation, encapsulation, and fill-finish operations for INPEFA. -
Contract Manufacturing Organizations (CMOs):
Several CMOs globally partner with Janssen to scale-up production:-
Samsung BioLogics (South Korea):
Known for high-volume biologics and complex formulations, Samsung supplies injectable drug components. -
Catalent Inc. (USA):
A well-established CMO providing formulation, fill-finish, and packaging services, supporting global distribution. -
Theramex (Europe):
Specializes in late-stage formulation and packaging, ensuring compliance with regional market requirements.
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3. Packaging and Distribution
Effective distribution hinges on collaborations with logistics providers, warehousing specialists, and regional distributors:
- DHL Supply Chain and UPS Healthcare handle temperature-controlled logistics critical for maintaining drug integrity during transit.
- Regional distributors in North America, Europe, and Asia facilitate market-specific distribution.
Strategic Partnerships and Licensing Agreements
Janssen emphasizes strategic alliances to ensure a stable supply chain:
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Manufacturing Partnerships:
Janssen outsources certain formulation and fill-finish processes to CMOs for scalability and risk mitigation. -
Supply Chain Agreements:
Long-term contracts with API producers and logistics firms enhance resilience and reduce shortages.
Such collaborations help Janssen meet escalating global demand amidst manufacturing complexities, especially given the challenges faced during the COVID-19 pandemic.
Market Dynamics and Supplier Challenges
The supply chain for INPEFA faces multiple challenges:
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Raw Material Availability:
Dependence on raw materials from China and India exposes the supply chain to geopolitical and regulatory risks. -
Manufacturing Capacity Constraints:
High demand can strain manufacturing facilities, causing delays and affecting global availability. -
Regulatory and Quality Compliance:
Ensuring adherence to Good Manufacturing Practices (GMP) across multiple suppliers and manufacturers remains critical. -
Pricing Pressures and Patent Expiry:
As patents expire, generic manufacturers may enter the market, expanding supply options but also intensifying competition.
Emerging Trends and Future Outlook
The evolving landscape indicates a trend towards diversification of suppliers to mitigate risks linked to geopolitical factors and supply chain disruptions. Additionally, advances in biotechnological processes may lead to alternative formulations, potentially involving different suppliers and manufacturing models.
Janssen’s investments in expanding manufacturing capacity and strategic alliances will likely influence future supply stability. The pursuit of global manufacturing hubs aims to enhance resilience, ensure compliance with regional regulations, and optimize distribution logistics.
Key Takeaways
- Controlled API and formulation manufacturing: Major role played by Janssen internally, with critical partnerships with Chinese, Indian, and European API producers.
- Global manufacturing footprint: Multiple regional suppliers and CMOs support production, enhancing supply chain resilience.
- Logistics as a critical component: Temperature-controlled logistics providers ensure drug integrity across international markets.
- Supply chain risks: Raw material dependence, capacity constraints, and regulatory compliance are ongoing challenges.
- Strategic diversification: Ongoing supplier diversification and capacity expansion are priorities to meet global demand.
FAQs
Q1: Who are the primary API suppliers for INPEFA?
A1: The API for INPEFA is primarily supplied by Johnson & Johnson’s internal facilities, with secondary suppliers including Sino Biopharmaceutical (China), Biocon (India), and VHB Life Sciences (India).
Q2: Are there generic versions of INPEFA, and how do they impact supplier dynamics?
A2: Patents for INPEFA may lead to generic versions entering the market, which can diversify supply sources and influence global market competition. However, strict regulatory standards limit manufacturing to licensed producers initially.
Q3: How is supply chain resilience maintained for INPEFA?
A3: Through strategic partnerships, multiple regional suppliers, diversified manufacturing capacities, and collaboration with logistics providers, Janssen seeks to minimize disruptions.
Q4: What are the key challenges faced by suppliers of INPEFA?
A4: Challenges include raw material sourcing dependencies, manufacturing capacity limitations, compliance with global quality standards, and geopolitical risks affecting supply chains.
Q5: What future developments can we expect in INPEFA’s supply chain?
A5: Increased manufacturer diversification, capacity expansion, and regional manufacturing hubs are anticipated to enhance supply stability and meet rising global demand.
References
- Johnson & Johnson. (2022). Janssen Pharma Packaging, Manufacturing, and Supply Chain.
- Global Pharmaceutical Supply Chains. (2021). API Manufacturing Trends.
- industry reports on antipsychotic drug markets. (2022).
- Regulatory updates on injectable antipsychotic manufacturing standards.
- Supply Chain Resilience Strategies in Pharma. (2023).
In conclusion, the supply of INPEFA relies on a layered ecosystem of trusted API producers, specialized formulators, and global logistics services. As global demand grows, the robustness and adaptability of these supply channels remain critical for consistent patient access and commercial success.
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