Suppliers and packagers for DORYX

DORYX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795	NDA	Mayne Pharma Commercial LLC	51862-560-00	1 BOTTLE in 1 CARTON (51862-560-00) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE	2023-01-02
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795	NDA	Mayne Pharma Commercial LLC	51862-560-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-560-60)	2023-01-02
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795	NDA AUTHORIZED GENERIC	Mayne Pharma Commercial LLC	68308-716-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-716-30)	2016-02-01
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795	NDA AUTHORIZED GENERIC	Mayne Pharma Commercial LLC	68308-716-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-716-60)	2016-02-01

Doryx Drug Manufacturing Supply Chain

Last updated: February 19, 2026

Doryx, a brand name for delayed-release doxycycline hyclate, is an antibiotic used to treat various bacterial infections and certain skin conditions. The manufacturing of Doryx involves a complex supply chain encompassing active pharmaceutical ingredient (API) sourcing, excipient procurement, drug product manufacturing, and packaging. Key suppliers for Doryx include companies specializing in the production of doxycycline hyclate and the inert ingredients necessary for tablet formulation.

Who are the Primary Suppliers of Doryx API?

The primary active pharmaceutical ingredient for Doryx is doxycycline hyclate. Sourcing this API is critical for manufacturers. Global API manufacturers, often based in China and India, are significant suppliers. Specific companies that have historically supplied or are capable of supplying doxycycline hyclate API include:

• Teva Pharmaceutical Industries Ltd. Teva is a global pharmaceutical company with significant API manufacturing capabilities.
• Lupin Ltd. An Indian multinational pharmaceutical company with a broad portfolio of APIs.
• Sun Pharmaceutical Industries Ltd. Another major Indian pharmaceutical firm with substantial API production.
• Dr. Reddy's Laboratories. An Indian multinational pharmaceutical company with a strong focus on API manufacturing.
• Ascend Laboratories LLC. A U.S.-based pharmaceutical company that may source APIs from various global manufacturers.

The specific suppliers for the currently marketed Doryx product are proprietary and may vary over time based on contracts and regulatory approvals. Manufacturers often qualify multiple suppliers to ensure supply chain resilience and competitive pricing.

What Excipients are Required for Doryx Formulation?

Doryx is a delayed-release tablet. This formulation requires specific excipients to ensure the drug is released at the intended site of action in the gastrointestinal tract. Key excipients include:

• Fillers/Diluents: Provide bulk to the tablet. Common examples include microcrystalline cellulose and lactose.
• Binders: Hold the ingredients together to form granules. Examples include povidone and hydroxypropyl methylcellulose (HPMC).
• Disintegrants: Help the tablet break apart in the gastrointestinal tract. Examples include croscarmellose sodium and sodium starch glycolate.
• Lubricants: Prevent sticking to tablet presses. Examples include magnesium stearate and stearic acid.
• Glidants: Improve powder flow. An example is colloidal silicon dioxide.
• Coating Agents: Form the delayed-release barrier. These often involve polymers like methacrylic acid copolymers (e.g., Eudragit® series) and plasticizers such as triethyl citrate.

Suppliers of these excipients are often specialized chemical companies with pharmaceutical-grade manufacturing facilities. Companies like BASF SE, Evonik Industries AG, and Croda International Plc are major global suppliers of pharmaceutical excipients. The specific grades and types of excipients are dictated by the drug formulation and regulatory requirements.

Who Manufactures the Doryx Drug Product?

The manufacturing of the finished Doryx dosage form is typically carried out by pharmaceutical companies with Good Manufacturing Practice (GMP) certified facilities. The brand holder for Doryx has historically been Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals). Bausch Health may manufacture Doryx in its own facilities or contract with a third-party Contract Manufacturing Organization (CMO).

CMOs that specialize in solid oral dosage forms and delayed-release technologies would be potential manufacturing partners. These organizations must adhere to stringent regulatory standards set by bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Examples of large CMOs capable of such manufacturing include:

• Catalent, Inc.
• Thermo Fisher Scientific (Patheon)
• Lonza Group AG

The selection of a CMO depends on factors such as production capacity, technical expertise in delayed-release formulations, regulatory compliance history, and cost.

What are the Packaging Requirements for Doryx?

Doryx tablets are typically packaged in blister packs or bottles. The packaging materials must protect the drug from moisture, light, and physical damage.

• Blister Packs: Commonly use polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), or aluminum foil for the blister cavities and aluminum foil for the lidding. Suppliers for these materials are often specialized plastic and metal foil manufacturers.
• Bottles: Typically made from high-density polyethylene (HDPE) or glass. Closures, such as screw caps with induction seals, are also critical components.

Key packaging suppliers include companies that produce:

• Pharmaceutical-grade plastics: Such as Amcor plc and Berry Global Group, Inc.
• Aluminum foils: For blister lidding and specialty packaging applications.
• Glass or plastic containers: For bottle packaging.
• Labeling and printing services: For cartons and inserts.

The choice of packaging also considers child-resistance requirements and tamper-evident features.

What Regulatory Considerations Impact the Doryx Supply Chain?

The supply chain for Doryx is subject to extensive regulatory oversight. The FDA, EMA, and other national regulatory agencies mandate strict adherence to GMP for API and drug product manufacturing.

Key regulatory aspects include:

• API Source Verification: Manufacturers must ensure their API suppliers meet GMP standards and are registered with regulatory authorities. Drug Master Files (DMFs) are often submitted by API manufacturers to support regulatory applications.
• Excipient Qualification: Excipients must meet pharmacopeial standards (e.g., USP, EP) and be sourced from qualified suppliers.
• Manufacturing Facility Inspections: Both in-house and contract manufacturing facilities are subject to regular inspections to verify compliance.
• Supply Chain Security: Measures to prevent counterfeiting and ensure product integrity throughout distribution are essential. This includes track-and-trace regulations.
• Change Control: Any changes to suppliers, manufacturing processes, or materials require thorough validation and potential regulatory notification or approval.

The Drug Supply Chain Security Act (DSCSA) in the United States requires pharmaceutical manufacturers to implement systems for product tracing and verification, impacting how Doryx is distributed and managed.

What are the Key Dates and Milestones in Doryx's Regulatory History?

Understanding key regulatory dates provides context for the current supply chain dynamics. Doryx (doxycycline hyclate) has been available for many years, with various formulations and brand names.

• Original Approval of Doxycycline: Doxycycline itself has a long history, with initial FDA approvals dating back to the 1960s.
• Introduction of Delayed-Release Formulations: Specific delayed-release formulations, such as that marketed as Doryx, have undergone their own approval processes. For example, an extended-release formulation was approved by the FDA in 2006.
• Patent Expirations: Patents covering specific formulations or manufacturing processes for Doryx have expired, leading to the introduction of generic versions. The expiration of key patents would have opened the market to generics and potentially influenced the supplier landscape as multiple generic manufacturers entered.
• FDA Enforcement Actions or Recalls: Any FDA enforcement actions, warning letters, or product recalls related to manufacturing quality or supply chain issues for doxycycline products would significantly impact supplier relationships and regulatory scrutiny. Specific dates for such events would be found in FDA databases.

The continuous oversight and evolving regulatory landscape mean that supply chain partners must maintain a state of compliance.

How is Supply Chain Resilience Managed for Doryx?

Pharmaceutical supply chains, including that of Doryx, face risks from geopolitical instability, natural disasters, raw material shortages, and manufacturing disruptions. Manufacturers manage resilience through:

• Dual Sourcing: Qualifying multiple suppliers for critical APIs and excipients. This mitigates risk if one supplier encounters production issues or faces regulatory challenges.
• Geographic Diversification: Sourcing from suppliers located in different geographical regions to avoid concentration of risk.
• Inventory Management: Maintaining strategic buffer stocks of APIs, intermediates, and finished products.
• Robust Quality Agreements: Establishing clear quality and supply agreements with all vendors, detailing performance expectations, audit rights, and contingency plans.
• Supply Chain Mapping: Gaining visibility into the entire supply chain, including tier-2 and tier-3 suppliers, to identify potential vulnerabilities.
• Regulatory Intelligence: Proactively monitoring regulatory changes and enforcement trends that could impact suppliers.

The management of the Doryx supply chain requires constant vigilance and strategic planning to ensure uninterrupted product availability for patients.

What are the Primary Risks to the Doryx Supply Chain?

The Doryx supply chain faces several inherent risks common to pharmaceutical manufacturing:

• API Availability and Quality: Reliance on a limited number of global API manufacturers can lead to shortages or quality control issues. Geopolitical tensions or trade disputes can disrupt supply from major API producing regions like China and India.
• Excipient Shortages: Specific pharmaceutical-grade excipients may experience supply constraints if demand outstrips production capacity or if a key supplier faces operational issues.
• Manufacturing Disruptions: Issues at manufacturing sites, including equipment failures, contamination events, or labor disputes, can halt production.
• Regulatory Non-Compliance: A supplier failing to meet GMP standards can lead to product recalls, import alerts, or the need to quickly re-qualify alternative suppliers, causing significant delays and costs.
• Transportation and Logistics: Delays or disruptions in shipping, warehousing, or customs clearance can impact product delivery timelines.
• Counterfeiting and Diversion: The pharmaceutical supply chain is vulnerable to counterfeit products entering the market, necessitating robust serialization and track-and-trace measures.

Mitigating these risks involves rigorous supplier qualification, continuous monitoring, and maintaining diversified sourcing strategies.

Key Takeaways

The Doryx supply chain involves specialized API manufacturers, excipient suppliers, drug product manufacturers, and packaging providers. Key suppliers of doxycycline hyclate API are often located in Asia, while excipients come from global chemical companies. Bausch Health Companies Inc. is historically associated with the Doryx brand, potentially utilizing its own facilities or contract manufacturers. Regulatory compliance, particularly GMP, is paramount at every stage, from API sourcing to finished product distribution. Supply chain resilience is managed through dual sourcing, inventory buffers, and comprehensive quality agreements, while risks include API availability, manufacturing disruptions, and regulatory non-compliance.

FAQs

What are the typical lead times for sourcing doxycycline hyclate API?

Lead times for pharmaceutical APIs can range from 3 to 9 months, depending on the supplier's existing production schedule, batch size, and any specific quality testing or regulatory documentation required.

How does the DSCSA impact Doryx packaging suppliers?

The DSCSA mandates product serialization and traceability, requiring packaging suppliers to provide materials that can accommodate unique product identifiers (e.g., Data Matrix codes) and potentially integrate with clients' serialization systems.

What is the role of a Contract Manufacturing Organization (CMO) in the Doryx supply chain?

A CMO can provide specialized manufacturing capabilities for Doryx, particularly for complex formulations like delayed-release tablets, allowing the brand owner to focus on marketing and distribution while ensuring GMP compliance.

How are excipient suppliers qualified for use in Doryx?

Excipient suppliers are qualified through rigorous audits of their manufacturing facilities, assessment of their quality management systems, review of pharmacopeial compliance, and often through batch testing of the excipient to ensure it meets specification.

What happens if a primary API supplier for Doryx experiences a significant quality failure?

If a primary API supplier fails quality standards, the brand holder would need to immediately activate secondary suppliers if qualified, or rapidly qualify new suppliers, which can involve extensive testing, validation, and regulatory submissions, potentially leading to product shortages.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file-system/drug-master-files-dmfs [2] U.S. Food and Drug Administration. (n.d.). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa [3] Bausch Health Companies Inc. (n.d.). Our Products. Retrieved from https://www.bauschhealth.com/our-products (Note: Specific product manufacturing details are not publicly disclosed on company websites). [4] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing-quality/good-manufacturing-practice-gmp [5] United States Pharmacopeia. (n.d.). USP General Chapters. Retrieved from https://www.uspnf.com/official-text/current/general-chapters