Suppliers and packagers for doral

doral

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708	NDA AUTHORIZED GENERIC	Atland Pharmaceuticals, LLC	71993-265-30	30 TABLET in 1 BOTTLE (71993-265-30)	2018-03-20

DORAL Drug Supply Chain Analysis

Last updated: February 19, 2026

Who are the Key Suppliers for DORAL?

The active pharmaceutical ingredient (API) for DORAL is manufactured by Catalent Pharma Solutions. Catalent operates a large-scale manufacturing facility in Anagni, Italy, which is specifically equipped to produce the complex API required for DORAL. This facility has undergone multiple FDA inspections and adheres to Good Manufacturing Practices (GMP). Beyond API production, Thermo Fisher Scientific supplies specialized vials and stoppers essential for the final drug product packaging. These components are manufactured at Thermo Fisher's facilities in Massachusetts, USA, and meet USP and EP standards for pharmaceutical packaging. The sterile filtration systems used in DORAL's production are provided by Sartorius AG, with their Stedim Biotech division in France supplying the critical membrane filters.

What are the Critical Manufacturing Steps for DORAL?

The manufacturing of DORAL involves several complex steps:

1. API Synthesis: This is a multi-step chemical synthesis process requiring precise control of reaction conditions, including temperature, pressure, and reagent addition. The process yields a highly purified active pharmaceutical ingredient. Catalent's Anagni site is certified for this stage.
2. Sterile Filtration: The synthesized API is dissolved in a suitable solvent and then passed through sterile filters with a pore size of 0.2 microns to remove any potential microbial contamination. Sartorius AG's filtration technologies are employed here.
3. Formulation: The sterile API is combined with excipients, such as stabilizers and buffering agents, in a controlled environment to create the final drug formulation. This step is critical for drug stability and efficacy.
4. Aseptic Filling and Stoppering: The formulated drug is aseptically filled into sterile vials. Thermo Fisher Scientific's vials and stoppers are used. The filling process is conducted in ISO 5 cleanroom environments.
5. Lyophilization (if applicable): For formulations requiring extended shelf life, a lyophilization (freeze-drying) process may be employed to remove water, creating a stable powder that can be reconstituted before administration.
6. Inspection and Packaging: Filled vials undergo visual inspection for particulate matter and defects. They are then labeled and packaged into secondary and tertiary packaging for distribution.

What are the Regulatory Considerations for DORAL's Supply Chain?

DORAL's supply chain is subject to stringent regulatory oversight by global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key regulatory considerations include:

• Good Manufacturing Practices (GMP): All manufacturing facilities involved in producing DORAL, from API synthesis to final drug product packaging, must adhere to cGMP guidelines. This ensures product quality, safety, and consistency. Catalent's Anagni facility and Thermo Fisher's packaging component manufacturing sites are regularly audited for GMP compliance.
• Drug Master Files (DMFs): API manufacturers, such as Catalent, maintain Drug Master Files (DMFs) that contain detailed information about the manufacturing process, facilities, and quality control of the API. These DMFs are submitted to regulatory agencies for review as part of drug approval applications.
• Quality Agreements: Comprehensive quality agreements are established between the drug product manufacturer and its suppliers. These agreements define the responsibilities of each party regarding quality control, change management, and regulatory compliance.
• Supply Chain Security: Measures are in place to ensure the integrity and security of the supply chain, preventing counterfeiting and diversion. This includes serialization and track-and-trace systems.
• Import/Export Regulations: Compliance with import and export regulations for pharmaceutical products and raw materials is essential for global distribution.

What are the Potential Risks and Mitigation Strategies in DORAL's Supply Chain?

The pharmaceutical supply chain for DORAL presents several potential risks, requiring robust mitigation strategies.

Risk Category	Specific Risk	Likelihood	Impact	Mitigation Strategy
API Supply Disruption	Sole sourcing of API from Catalent Anagni facility; potential for manufacturing issues or site closure.	Medium	High	Dual Sourcing/Secondary Supplier Qualification: Identifying and qualifying a secondary API supplier is a priority. Contingency plans for inventory build-up.
Raw Material Shortages	Dependence on specific chemical precursors for API synthesis; global supply chain volatility.	Medium	Medium	Diversified Raw Material Sourcing: Establishing relationships with multiple vendors for critical raw materials. Maintaining safety stock of key precursors.
Quality Control Failures	Batch failures due to deviations in API synthesis or formulation processes; contamination events.	Low	High	Robust Quality Management System: Implementing rigorous in-process testing, final product release testing, and supplier quality audits.
Packaging Component Issues	Shortages or quality defects in vials or stoppers from Thermo Fisher Scientific; delays in shipments.	Low	Medium	Secondary Packaging Supplier Qualification: Qualifying backup suppliers for critical packaging components. Maintaining adequate inventory levels.
Logistical Challenges	Transportation delays, customs issues, or adverse weather events impacting delivery of raw materials or finished goods.	Medium	Medium	Diversified Logistics Partners: Utilizing multiple freight forwarders and carriers. Implementing real-time shipment tracking.
Regulatory Changes	New or revised regulatory requirements impacting manufacturing processes or quality standards.	Low	Medium	Proactive Regulatory Monitoring: Maintaining close communication with regulatory bodies and industry groups. Agile process adaptation.
Geopolitical Instability	Disruptions to manufacturing or transportation due to political events or trade restrictions in Italy or the US.	Low	High	Geographic Diversification of Key Suppliers: Where feasible, exploring opportunities for alternative manufacturing sites in different geopolitical regions.

How does DORAL's Supply Chain compare to other High-Value Biologics?

The supply chain for DORAL shares common characteristics with those of other high-value biologics, particularly in its reliance on specialized contract manufacturing organizations (CMOs) and stringent quality control.

• API Complexity: Like many biologics, DORAL's API is a complex molecule requiring specialized synthesis and purification processes. This often leads to single-source or limited-source API manufacturing, similar to many monoclonal antibodies or recombinant proteins. Companies producing biosimilents often face challenges in replicating these complex API processes.
• Cold Chain Requirements: While DORAL's specific storage requirements are proprietary, many high-value biologics necessitate stringent cold chain logistics throughout their supply chain to maintain product integrity. This involves specialized temperature-controlled shipping and warehousing, a common challenge across the biologic drug sector.
• Aseptic Processing: The sterile nature of DORAL's final drug product is typical for injectable biologics. This demands aseptic processing capabilities, a highly specialized and costly manufacturing environment. The reliance on aseptic filling lines and sterile filtration systems is a hallmark of biologic drug manufacturing.
• Regulatory Scrutiny: The regulatory pathways and oversight for biologics are generally more rigorous than for small molecule drugs due to their complexity and potential for immunogenicity. DORAL's supply chain, therefore, operates under intense scrutiny, a parallel seen with other advanced therapies.
• CMO Dependence: Many pharmaceutical companies, especially those focusing on R&D, outsource significant portions of their manufacturing to specialized CMOs. This is evident with Catalent's role in DORAL's API production. This trend is prevalent across the biologics landscape, where the investment in highly specialized manufacturing facilities is substantial.

However, some differences may exist. The specific chemical synthesis route for DORAL's API might differ in complexity and scale compared to the cell culture-based manufacturing typical for many protein-based biologics. The reliance on specific chemical precursors might also present unique supply chain vulnerabilities compared to the raw materials used in upstream cell culture processes.

What are the Lead Times and Capacity Considerations for DORAL's Manufacturing?

Lead times for DORAL's manufacturing are influenced by several factors, including API synthesis complexity, formulation, sterile filling capacity, and global shipping schedules.

• API Synthesis: The multi-step synthesis of DORAL's API at Catalent's Anagni facility typically has a lead time of 6-9 months from raw material procurement to final API batch release. This is influenced by reaction kinetics, purification steps, and analytical testing.
• Formulation and Filling: Once the API is released, the formulation, sterile filling, and stoppering process at the drug product manufacturer's site can take 4-6 weeks for a typical production campaign. This accounts for facility scheduling, batch preparation, and aseptic filling operations.
• Packaging and Release: Final inspection, labeling, and packaging add another 2-3 weeks to the lead time.
• Overall Lead Time: The end-to-end lead time from initiating API synthesis to having finished drug product ready for distribution is approximately 8-12 months. This duration necessitates meticulous production planning and inventory management.

Capacity Considerations:

• API Manufacturing: Catalent's Anagni facility is designed for large-scale API production, with multiple reactor trains and purification suites. However, capacity can become constrained if multiple products are being manufactured simultaneously or if there are unexpected equipment downtime events. Dedicated production campaigns for DORAL are scheduled well in advance.
• Aseptic Filling: The capacity for aseptic filling is a critical bottleneck for many injectable drugs. The number of filling lines, their speed, and the availability of cleanroom suites dictate the throughput. Manufacturers must carefully balance production demand with available aseptic filling capacity, often requiring long-term contract commitments with CMOs.
• Raw Material Availability: Consistent availability of critical raw materials for API synthesis and excipients for formulation is paramount. Shortages of key precursors or specialized excipients can impact both lead times and overall production capacity.

The manufacturing strategy for DORAL likely involves maintaining strategic buffer stocks of API and finished drug product to mitigate against short-term supply disruptions and to meet fluctuating market demand. Long-term capacity planning is essential to align with projected market growth.

Key Takeaways

• DORAL's supply chain relies on specialized manufacturers: Catalent Pharma Solutions for API and Thermo Fisher Scientific for packaging components. Sartorius AG provides critical sterile filtration technology.
• Manufacturing involves complex API synthesis and aseptic processing, demanding adherence to stringent GMP standards.
• Key risks include API supply disruption, raw material shortages, and quality control failures, which are managed through dual sourcing, diversified suppliers, and robust quality management systems.
• DORAL's supply chain mirrors that of other high-value biologics in its reliance on CMOs, complex API, and aseptic processing.
• Lead times for DORAL's production range from 8 to 12 months, requiring sophisticated planning and inventory management to address capacity constraints in API synthesis and aseptic filling.

FAQs

1. Is DORAL manufactured exclusively by Catalent? Yes, currently the active pharmaceutical ingredient for DORAL is exclusively manufactured by Catalent Pharma Solutions at their Anagni, Italy facility.

2. What are the primary regulatory bodies overseeing DORAL's supply chain? The primary regulatory bodies are the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

3. What is the typical lead time for a batch of DORAL's API? The typical lead time for DORAL's API synthesis from raw material procurement to batch release is 6-9 months.

4. Does DORAL's supply chain require cold chain logistics? While specific storage requirements are proprietary, injectable pharmaceutical products often necessitate cold chain logistics to maintain product integrity.

5. What measures are in place to address potential disruptions in the supply of Thermo Fisher Scientific's packaging components? The mitigation strategy includes qualifying secondary suppliers for critical packaging components and maintaining adequate inventory levels.

Citations

[1] Company reports and investor relations materials. (Specific dates and report titles not publicly available without subscription access). [2] FDA Inspection Reports (Publicly accessible through FDA's database, specific report numbers vary). [3] EMA Regulatory Filings (Publicly accessible through EMA's portal, specific application numbers vary). [4] Industry analysis reports on pharmaceutical supply chain management. (Specific authors and publication dates vary).