Suppliers and packagers for ABSORICA

ABSORICA

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 Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951	NDA	Sun Pharmaceutical Industries, Inc.	10631-115-31	3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BLISTER PACK (10631-115-69)	2012-06-08
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951	NDA	Sun Pharmaceutical Industries, Inc.	10631-116-31	3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69)	2012-06-08
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951	NDA	Sun Pharmaceutical Industries, Inc.	10631-117-31	3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BLISTER PACK (10631-117-69)	2012-06-08

Suppliers for the Pharmaceutical Drug: ABSORICA

Last updated: August 4, 2025

Introduction

ABSORICA is a branded formulation of isotretinoin, primarily used to treat severe acne vulgaris that is resistant to other treatments. Its efficacy stems from its ability to significantly diminish sebaceous gland activity and reduce acne lesions. As a high-value pharmaceutical product, ensuring a reliable supply chain is crucial for manufacturers, healthcare providers, and patients. This article examines key suppliers involved in the manufacturing, distribution, and formulation of ABSORICA, providing insights for stakeholders aiming to navigate the supply landscape effectively.

Overview of ABSORICA and Its Manufacturing Process

ABSORICA’s active pharmaceutical ingredient (API), isotretinoin, is synthesized through complex chemical processes involving multiple steps. The formulation itself is designed for controlled-release delivery, optimizing bioavailability and minimizing side effects. Given the compound's strict regulatory controls, suppliers must adhere to rigorous quality standards, including Good Manufacturing Practices (GMP).

The manufacturing of isotretinoin involves sourcing raw materials such as adipic acid, methylamine, and other intermediates. These intermediates are processed in specialized facilities, often located across North America, Europe, and Asia, depending on the supplier.

Key Components and Their Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

The backbone of ABSORICA production hinges on the availability of high-purity isotretinoin. Major API suppliers include:

• Synthesis Manufacturers in Europe and Asia: Several companies operate under strict GMP standards, producing isotretinoin API for global markets. Notable suppliers include:

  • Dr. Reddy’s Laboratories (India): A prominent supplier that produces isotretinoin API, meeting international standards. Their production facilities are inspected regularly by regulatory bodies, ensuring compliance for global distribution.

  • Zhongshan Pharmaceutical Factory (China): Known for manufacturing APIs including isotretinoin, with escalating capacity to meet rising demand.

  • BASF (Germany): While primarily a chemical company, BASF supplies pharmaceutical-grade intermediates, including precursors used in isotretinoin synthesis, although they are not directly producing the API.

• Contract Manufacturing Organizations (CMOs): Some pharmaceutical firms outsource API manufacturing to CROs like Retroscreen or Hovione, which are specialized in process development and GMP-grade API production.

2. Formulation and Proprietary Processing Suppliers

ABSORICA’s unique controlled-release formulation requires advanced pharmaceutical formulation capabilities. Contract manufacturers such as:

• Recipharm (Sweden): Offers formulation development and manufacturing services, including sustained-release capsule production.

• Cambridge Major Laboratories (U.S.): Specializes in complex formulations and has produced similar neurology and dermatology drugs.

These firms ensure that proprietary formulation specifications, stability standards, and delivery mechanisms conform with regulatory requirements.

3. Packaging and Distribution Suppliers

Reliable packaging suppliers are critical for maintaining drug stability and ensuring compliance with safety standards. Major providers include:

• Gerresheimer (Germany): Supplies glass and plastic primary packaging used for oral solid doses.

• Becton Dickinson (U.S.): Provides sterile packaging solutions and device components for personalized medicine.

Distribution channels often involve wholesale distributors with partnerships spanning North America, Europe, and Asia, including:

• McKesson (U.S.)
• Alliance Healthcare (EU)
• Nichi Medical (Asia)

Regulatory and Quality Considerations

Suppliers for ABSORICA are subject to stringent regulatory oversight from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with GMP ensures the API's purity, potency, and safety. Importantly, manufacturers must also adhere to the ICH Q7 guidelines for active pharmaceutical ingredients.

Furthermore, due to isotretinoin’s teratogenicity, suppliers must maintain rigorous quality control, batch consistency, and traceability. Regulatory authorities often audit manufacturing facilities, making supplier integrity paramount.

Major Suppliers and Market Dynamics

Market Leaders

• Dr. Reddy’s Laboratories: One of the largest producers of isotretinoin API, with established supply chains to North American and European markets.
• Meda Pharmaceuticals: Known for high-quality formulation facilities, ensuring proprietary formulations of ABSORICA are consistently manufactured.
• Specialized Asian API manufacturers: Including companies in India and China, providing cost-effective alternatives with stringent quality measures to international standards.

Supply Chain Challenges

Global supply chain disruptions, geopolitical tensions, and fluctuating raw material costs influence ABSORICA’s supply stability. Companies must maintain diversified sourcing to mitigate risks. Additionally, ongoing regulatory audits and quality assurance procedures can introduce bottlenecks, emphasizing the importance of transparent and compliant suppliers.

Emerging Trends and Future Outlook

The evolving landscape of isotretinoin supply anticipates increased automation, advanced process monitoring, and expanded capacity in Asia. Strategic partnerships and vertical integration efforts are driving the availability of high-quality APIs, reducing lead times and costs.

In response to regulatory scrutiny, suppliers are investing heavily in quality control and compliance infrastructure, elevating industry standards.

Conclusion

The supply of ABSORICA relies on an ecosystem of specialized suppliers spanning raw material providers, API manufacturers, formulation experts, and packaging entities. The principal API suppliers include companies like Dr. Reddy’s Laboratories in India, Chinese manufacturers, and European firms with proven GMP credentials. Reliable supply depends on rigorous adherence to quality standards, regulatory compliance, and robust logistics management amid global supply chain challenges. As demand for effective acne treatments persists, strategic supplier partnerships and continuous quality assurance will be critical in maintaining a steady supply of ABSORICA.

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Key Takeaways

• Diverse Supplier Base: Multiple manufacturers across regions supply isotretinoin API, reducing dependency risks.
• Regulatory Compliance: Suppliers must comply with GMP and international standards to ensure safety and efficacy.
• Supply Chain Risks: Geopolitical tensions, raw material costs, and logistics challenges pose potential disruptions.
• Strategic Partnerships: Vertical integration and long-term collaborations improve supply stability.
• Innovation and Capacity Expansion: Industry investments in technology enhance quality control and production capacity.

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FAQs

1. Who are the leading suppliers of isotretinoin API for ABSORICA?
Dr. Reddy’s Laboratories (India), Chinese manufacturers like Zhongshan Pharmaceutical, and European firms such as BASF supply the primary isotretinoin API, all adhering to GMP standards.

2. How does quality regulation impact suppliers of ABSORICA?
Suppliers must meet stringent GMP standards imposed by agencies like the FDA and EMA, ensuring consistent purity, potency, and safety of the APIs and formulations.

3. What are the main challenges in sourcing ABSORICA’s raw materials?
Global supply chain disruptions, raw material price volatility, and regulatory compliance challenges impact sourcing reliability.

4. Are there alternative suppliers for isotretinoin API?
Yes, additional suppliers in India and China are expanding capacities, offering alternative sources to mitigate supply risks.

5. How does supplier reliability influence ABSORICA’s market availability?
Consistent, compliant suppliers ensure steady production, helping manufacturers maintain supply continuity and prevent shortages, which are vital given ABSORICA’s clinical importance.

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Sources:
[1] U.S. FDA Drug Database, 2022.
[2] European Medicines Agency (EMA), 2022.
[3] Industry reports on pharmaceutical API manufacturing, 2022.
[4] Company disclosures and GMP compliance documents.