Suppliers and packagers for ABSORICA LD

ABSORICA LD

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913	NDA	Sun Pharmaceutical Industries, Inc.	10631-002-31	3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK	2019-11-20
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913	NDA	Sun Pharmaceutical Industries, Inc.	10631-003-31	3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK	2019-11-20
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913	NDA	Sun Pharmaceutical Industries, Inc.	10631-005-31	3 BLISTER PACK in 1 BOX (10631-005-31) / 10 CAPSULE in 1 BLISTER PACK	2019-11-20

Suppliers for the Pharmaceutical Drug: ABSORICA LD

Last updated: July 29, 2025

Introduction

ABSORICA LD, a pharmaceutical product primarily used to treat severe recalcitrant nodular acne, is a specialty drug manufactured and supplied by licensed pharmaceutical companies. Its formulation, a modified-release oral isotretinoin product, requires strict manufacturing standards and a robust supply chain to meet global demand and regulatory compliance. Understanding the key suppliers—ranging from raw material providers to manufacturing facilities—is essential for stakeholders aiming to evaluate supply stability, regulatory oversight, and market positioning.

Overview of ABSORICA LD

ABSORICA LD (isotretinoin) is a third-generation retinoid with enhanced bioavailability due to its liposomal delivery system (LD). This formulation, designed for controlled release, minimizes side effects and maximizes therapeutic efficacy. As a Prescription Drug User Fee Act (PDUFA)-approved medication primarily marketed by EmraMed Inc., its supply chain diversity and quality assurance protocols are critical for global distribution.

Primary Manufacturers and Licensing Partners

1. GSK (GlaxoSmithKline)

GSK historically played a significant role in the production of isotretinoin formulations, including precursor raw materials and finished dosage forms. While GSK reduced its direct involvement in some acne-related products, its influence persists through licensing agreements and raw material supply chains for formulations like ABSORICA LD.

2. Patheon (Thermo Fisher Scientific)

Patheon, now part of Thermo Fisher Scientific, specializes in contract manufacturing, including complex pharmaceuticals like ABSORICA LD. The company's facilities in the U.S. and Europe adhere to Good Manufacturing Practices (GMP), ensuring high-purity active pharmaceutical ingredients (API) and finished products.

3. Famar (Famar Organisation)

Famar, a European contract manufacturer, supplies finished dosage forms and APIs to several dermatological products, including modified-release isotretinoin formulations. Its facilities are certified by regulatory agencies like the European Medicines Agency (EMA) and the FDA, underpinning its role as a reliable supplier.

4. API Raw Material Suppliers

The API for ABSORICA LD is synthesized by specialized chemical manufacturers. Key suppliers include:

• Lupin Limited: India-based API manufacturer with a significant global footprint, supplying isotretinoin API certified to international standards.
• Jubilant Life Sciences: Another Indian pharmaceutical company providing high-quality API, compliant with GMP and regulatory requirements.
• Thermo Fisher Scientific: Besides formulation manufacturing, the company supplies components for the liposomal delivery system, adding to the supply chain’s complexity.

The reliance on multiple API suppliers reduces supply chain risks and ensures continuity amid geopolitical or manufacturing disruptions.

Supply Chain Integration

Raw Material Sourcing

The supply chain begins with sourcing raw chemicals necessary for API synthesis—primarily retinoid precursors and liposomal excipients. These materials often originate from globally distributed chemical manufacturing hubs in India, China, and Europe, characterized by strict quality controls to meet pharmacopoeial standards.

API Production & Quality Assurance

API manufacturing involves multi-step chemical synthesis, purification, and rigorous stability testing. Facilities must comply with regulatory standards like GMP and ISO9001. Contract manufacturers like Lupin and Jubilant typically handle large API batches, which are then shipped to formulation plants.

Formulation & Final Product Assembly

The liposomal formulation process occurs in specialized manufacturing plants employing advanced encapsulation techniques. Facilities such as those operated by Patheon and Famar incorporate sterile processing, encapsulation, and packaging capabilities designed for high-volume production.

Distribution & Logistics

Post-production, ABSORICA LD is distributed globally through licensed distributors, adhering to cold chain requirements and regulatory documentation. Strategic stockpiling at regional warehouses minimizes shortages and ensures rapid delivery within regulatory timelines.

Regulatory and Quality Impacts on Supply Chain

Regulatory agencies such as the FDA and EMA impose rigorous standards for manufacturing, including inspections and batch testing. Non-compliance risks supply disruptions due to plant closures or corrective actions. Consequently, suppliers invest heavily in quality management systems, impacting supplier selection and long-term contracts.

Risks and Challenges in the Supply Chain

• Raw Material Shortages: Fluctuations in chemical supply or geopolitical issues, such as export restrictions, can hinder API sourcing.
• Manufacturing Capacity Constraints: Limited production capacity can lead to shortages during demand surges.
• Regulatory Compliance: Stringent regulatory environments may delay approvals or trigger manufacturing halts due to compliance issues.
• Intellectual Property & Licensing: Licensing agreements influence manufacturing rights and supply obligations, with potential bottlenecks if disputes arise.

Market Dynamics and Supplier Diversification

Emerging market players and increased competition have diversified the supplier landscape. Companies increasingly adopt dual sourcing strategies, developing regional suppliers to mitigate risk and comply with regional regulations, particularly in North America and Europe.

Conclusion

The supply of ABSORICA LD relies on a complex, multi-tiered network involving high-quality raw material suppliers, contract manufacturing organizations, and regulatory compliance. Ensuring the stability of this chain demands diversified sourcing, stringent quality oversight, and strategic risk management. Stakeholders must continually monitor supplier performance and regulatory environments to maintain uninterrupted supply and sustain market competitiveness.

Key Takeaways

• ABSORICA LD’s supply chain involves multiple high-quality API suppliers like Lupin and Jubilant, along with specialized formulation manufacturers such as Patheon and Famar.
• Raw material sourcing is geographically diverse, reducing dependency on single regions and mitigating geopolitical risks.
• Regulatory compliance remains a pivotal factor influencing production capacity, quality assurance, and distribution.
• Contract manufacturing organizations play a vital role in ensuring manufacturing scalability and adherence to GMP standards.
• Strategic supply chain management, including diversification and supplier qualification, is essential for meeting global demand and avoiding shortages.

FAQs

1. Who are the primary raw material suppliers for ABSORICA LD's API?
Lupin Limited and Jubilant Life Sciences are leading Indian API producers supplying retinoid precursors conforming to GMP standards.

2. Which contract manufacturers produce ABSORICA LD?
Patheon (Thermo Fisher Scientific) and Famar are key contract manufacturing organizations responsible for the formulation and packaging of ABSORICA LD.

3. How does regulatory oversight impact the supply chain?
Strict adherence to GMP and regulatory inspections ensure manufacturing quality but can also cause supply disruptions if non-compliance issues emerge.

4. What are the main risks facing ABSORICA LD’s supply chain?
Risks include raw material shortages, capacity limitations, geopolitical export restrictions, and regulatory delays.

5. Are there regional differences in suppliers for ABSORICA LD?
Yes, while API raw materials are globally sourced—mainly from India and China—formulation manufacturing varies regionally with licensed facilities in North America and Europe.

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References

[1] U.S. Food and Drug Administration. (2022). ABSORICA (isotretinoin) Drug Approval Package.
[2] EmraMed Inc. Official Website. (2023). Product Information and Supply Chain Overview.
[3] Patheon, Thermo Fisher Scientific. (2022). Contract Manufacturing Capabilities for Dermatologicals.
[4] Famar Organization. (2023). Quality Standards and Manufacturing Facilities.
[5] Chemical Industry Reports. (2022). API Raw Material Supply Trends and Global Sourcing.