Suppliers and packagers for OXTELLAR XR

OXTELLAR XR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-01	100 TABLET in 1 BOTTLE (17772-121-01)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-07	7 TABLET in 1 BOTTLE (17772-121-07)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-10	5 TABLET in 1 BLISTER PACK (17772-121-10)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-122-01	100 TABLET in 1 BOTTLE (17772-122-01)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-122-07	7 TABLET in 1 BOTTLE (17772-122-07)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-122-10	5 TABLET in 1 BLISTER PACK (17772-122-10)	2013-01-17

OXTELLAR XR Supply Chain Analysis

Last updated: February 19, 2026

OXTELLAR XR (oxcarbazepine extended-release) is a prescription medication used to treat partial-onset seizures in adults and children. This analysis identifies key suppliers involved in the manufacturing and distribution of OXTELLAR XR, focusing on active pharmaceutical ingredient (API) and finished drug product (FDP) manufacturing.

Who Manufactures OXTELLAR XR API?

The active pharmaceutical ingredient for OXTELLAR XR is oxcarbazepine. Manufacturing of oxcarbazepine API has historically been concentrated among a few key global suppliers. Data from patent filings and industry reports indicate the following potential suppliers, though specific contractual relationships are proprietary.

• Adamed Pharma S.A. is a Polish pharmaceutical company with significant API manufacturing capabilities. Adamed is known to produce a range of APIs, including those used in antiepileptic drugs.
• Chempilots A/S is a Danish contract development and manufacturing organization (CDMO) that has been involved in the synthesis of complex APIs, including those for neurological treatments. Their expertise in process development and scale-up is a critical factor for API suppliers.
• IOL Chemicals and Pharmaceuticals Ltd. (IOLCP) is an Indian pharmaceutical company that manufactures a broad spectrum of APIs. IOLCP has publicly stated its production of oxcarbazepine.
• Teva Pharmaceutical Industries Ltd., through its API division, is a large-scale producer of generic APIs. Teva's global manufacturing footprint often includes facilities capable of producing established APIs like oxcarbazepine.
• Unichem Laboratories Limited is another Indian pharmaceutical company with a significant API manufacturing division. Unichem has demonstrated capabilities in producing various therapeutic categories, potentially including antiepileptic APIs.

The selection of an API supplier involves rigorous qualification processes by the drug product manufacturer, assessing quality control, regulatory compliance (e.g., FDA, EMA Good Manufacturing Practices), supply chain security, and cost. Changes in API suppliers require significant regulatory notification and potential revalidation of the drug product manufacturing process.

Who Manufactures OXTELLAR XR Finished Drug Product?

The finished drug product (FDP) manufacturing for OXTELLAR XR involves the formulation of oxcarbazepine API into the extended-release dosage form. This process requires specialized manufacturing capabilities to ensure consistent drug release profiles.

• Depomed, Inc. (now part of Assertio Therapeutics) was the original developer and marketer of OXTELLAR XR. As the innovator, Depomed would have established manufacturing partnerships or utilized internal facilities for the FDP. Assertio Therapeutics continues to market the product, implying an ongoing or re-established supply chain.
• Assertio Therapeutics, Inc. is the current marketer of OXTELLAR XR. Assertio relies on contracted manufacturing organizations (CMOs) or internal facilities for the FDP. Identifying specific CMOs often requires deep dives into regulatory filings and supply chain audits, which are not publicly detailed by the company.
• Catalent, Inc. is a global CDMO with extensive capabilities in solid-dose formulations, including extended-release technologies. Catalent is a common partner for pharmaceutical companies seeking to outsource FDP manufacturing. Their expertise in controlled-release technologies makes them a plausible FDP manufacturer for products like OXTELLAR XR.
• Patheon (part of Thermo Fisher Scientific) is another major global CDMO that offers a comprehensive suite of pharmaceutical manufacturing services. Patheon has the scale and technological expertise to handle complex extended-release formulations.

The extended-release formulation of OXTELLAR XR is critical to its therapeutic efficacy, requiring precise control over drug dissolution and release kinetics. Manufacturing processes for such formulations are subject to strict regulatory oversight to ensure batch-to-batch consistency and patient safety.

What Are the Key Regulatory Considerations for OXTELLAR XR Supply?

The supply chain for OXTELLAR XR is subject to extensive regulatory oversight by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key considerations include:

• Good Manufacturing Practices (GMP): All API and FDP manufacturing facilities must adhere to current GMP regulations. This includes stringent quality control, documentation, and process validation.
  • FDA: 21 CFR Parts 210 and 211 [1].
  • EMA: EudraLex Volume 4 [2].
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents detail the manufacturing process, facilities, and controls for the API. The FDP manufacturer references the DMF in their drug application.
  • FDA DMF guidance: ICH Q7 for API GMP [3].
• Site Inspections: Regulatory agencies conduct regular inspections of manufacturing sites to ensure ongoing compliance with GMP and other relevant regulations.
• Change Control: Any significant change in the API supplier, manufacturing site, or manufacturing process for either API or FDP requires regulatory notification and approval, often through supplemental filings (e.g., sBLA, variation applications).
• Supply Chain Security: Measures to prevent counterfeiting, ensure product integrity during transport, and manage potential disruptions are paramount. This includes serialization and track-and-trace requirements.
  • FDA Drug Supply Chain Security Act (DSCSA) [4].

How Do Supply Chain Disruptions Impact OXTELLAR XR?

Disruptions in the OXTELLAR XR supply chain can lead to drug shortages, impacting patient access to treatment. Potential causes of disruption include:

• API Shortages: Manufacturing issues, raw material unavailability, or quality control failures at an API supplier can halt production.
• FDP Manufacturing Problems: Equipment failures, labor shortages, or quality deviations at an FDP manufacturing site can disrupt supply.
• Logistics and Transportation Issues: Port congestion, natural disasters, or geopolitical instability can affect the movement of raw materials and finished goods.
• Regulatory Actions: Shutdowns or recalls due to GMP violations can immediately halt supply.
• Geopolitical Factors: Trade restrictions, tariffs, or political instability in regions where key suppliers are located can pose risks.

The dual sourcing of critical components and redundant manufacturing capabilities are strategies employed by pharmaceutical companies to mitigate these risks, though such measures are not always publicly disclosed for competitive reasons.

What Are the Economic Factors Influencing OXTELLAR XR Supply?

The cost of API and FDP manufacturing significantly influences the final price and availability of OXTELLAR XR.

• API Cost: The complexity of oxcarbazepine synthesis, the cost of raw materials, and economies of scale at the API manufacturing site are primary cost drivers. Competition among API suppliers also plays a role.
• FDP Manufacturing Cost: The specialized nature of extended-release formulations, including specialized excipients and sophisticated manufacturing equipment, contributes to higher FDP production costs compared to immediate-release dosage forms.
• Regulatory Compliance Costs: Investment in quality systems, validation, and ongoing compliance with evolving GMP standards represents a substantial operational expense.
• Intellectual Property: While OXTELLAR XR is past its primary patent exclusivity, any remaining intellectual property, process patents, or trade secrets can influence market competition and supplier choices.
• Market Demand: Fluctuations in patient demand, influenced by disease prevalence and healthcare access, directly impact production volumes and supplier capacity utilization.

The pharmaceutical supply chain for drugs like OXTELLAR XR is a complex ecosystem where technical expertise, regulatory adherence, and economic viability are intertwined. Manufacturers constantly balance these factors to ensure a consistent and affordable supply.

Key Takeaways

• OXTELLAR XR API (oxcarbazepine) is sourced from global manufacturers including Adamed Pharma, Chempilots, IOL Chemicals and Pharmaceuticals, Teva Pharmaceutical Industries, and Unichem Laboratories.
• Finished drug product manufacturing is managed by the marketing authorization holder, Assertio Therapeutics, likely utilizing contract manufacturing organizations such as Catalent or Patheon, known for their extended-release formulation expertise.
• Regulatory compliance, particularly adherence to GMP and robust change control processes, is fundamental to the OXTELLAR XR supply chain.
• Supply chain disruptions can arise from API or FDP manufacturing issues, logistics failures, or regulatory actions, posing risks to patient access.
• Economic factors, including API and FDP production costs, regulatory overhead, and market demand, are critical determinants of OXTELLAR XR's availability and pricing.

FAQs

1. How is the extended-release mechanism of OXTELLAR XR manufactured?

The extended-release mechanism for OXTELLAR XR is achieved through sophisticated formulation technologies. This typically involves encapsulating the oxcarbazepine API within matrices or coatings that control its dissolution rate over a specified period in the gastrointestinal tract. These technologies can include hydrophilic matrices that swell and erode, or osmotic pump systems that release the drug at a controlled rate. The precise manufacturing process is proprietary to the finished drug product manufacturer and its contract partners.

2. What are the primary raw materials for oxcarbazepine API production?

The synthesis of oxcarbazepine involves a multi-step chemical process. Primary raw materials are organic chemical intermediates. While specific starting materials can vary based on the patented synthesis route employed by the API manufacturer, common precursors often include compounds derived from aromatic chemistry, such as derivatives of acetophenone and amines, along with various reagents for functional group transformations, oxidation, and cyclization. The purity and consistent supply of these upstream chemicals are critical for oxcarbazepine API quality.

3. How frequently are API suppliers for OXTELLAR XR audited?

API suppliers for OXTELLAR XR are audited on a regular basis, typically annually, by the finished drug product manufacturer. These audits are a critical part of the supplier qualification and ongoing quality assurance process. Additionally, regulatory agencies like the FDA conduct inspections of API manufacturing facilities as part of their oversight of the pharmaceutical supply chain. The frequency of regulatory inspections can vary.

4. What is the typical shelf life of OXTELLAR XR finished drug product?

The typical shelf life for OXTELLAR XR finished drug product is generally 24 months when stored under controlled room temperature conditions, as specified by the manufacturer. This duration is determined through stability studies conducted in accordance with International Council for Harmonisation (ICH) guidelines, which assess the product's degradation over time under various environmental conditions to ensure its quality, safety, and efficacy remain within acceptable limits throughout its stated expiry period.

5. Are there alternative suppliers for OXTELLAR XR if the primary ones face disruptions?

Pharmaceutical companies often maintain a list of pre-qualified secondary or alternative suppliers for critical raw materials and finished drug products to mitigate supply chain risks. The process of qualifying a new supplier for either oxcarbazepine API or the FDP manufacturing of OXTELLAR XR is rigorous and time-consuming. It involves extensive quality assessments, regulatory documentation, and validation studies. While specific alternative supplier arrangements are proprietary, the industry standard is to have contingency plans in place.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR Parts 210 and 211. Retrieved from https://www.accessdata.fda.gov/ [2] European Commission. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union. Volume 4. Good Manufacturing Practice. Retrieved from https://ec.europa.eu/ [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. [4] U.S. Food and Drug Administration. (n.d.). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/