Suppliers and packagers for ORACEA

ORACEA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805	NDA	Galderma Laboratories, L.P.	0299-3822-07	24 TRAY in 1 BOX (0299-3822-07) / 4 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK	2010-05-14
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805	NDA	Galderma Laboratories, L.P.	0299-3822-30	30 CAPSULE in 1 BOTTLE (0299-3822-30)	2010-05-14
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-668-30	30 CAPSULE in 1 BOTTLE (68308-668-30)	2023-02-27

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Oracea

Introduction
Oracea, a prescription medication primarily used to treat rosacea, is a branded formulation of doxycycline. Unlike traditional antibiotics, Oracea is designed for low-dose, sustained-release delivery, which minimizes antibiotic resistance concerns while exploiting doxycycline's anti-inflammatory properties. As a niche therapeutic agent, Oracea relies on a precise and controlled supply chain involving several key players, including primary pharmaceutical manufacturers, raw material suppliers, and distribution channels. An understanding of its sourcing landscape is imperative for stakeholders across the healthcare, logistics, and investment sectors.

Manufacturing of Oracea: The Role of Credited Pharmaceutical Companies
Oracea is marketed by Galderma, a leading dermatology-focused pharmaceutical company. Galderma holds the patent rights and oversees the entire production process, from formulation development to distribution [1]. The manufacturing process requires specialized facilities capable of producing low-dose doxycycline formulations under stringent Good Manufacturing Practices (GMP). Although Galderma controls the final product, they source raw materials, particularly doxycycline monohydrate, from global suppliers.

Raw Material Suppliers: Doxycycline Monohydrate
Doxycycline, the active pharmaceutical ingredient (API) in Oracea, is predominantly produced from chemical synthesis processes. Major suppliers of doxycycline monohydrate include:

• Hussain Daccus Pharmaceutical (India): Known for robust antibiotic intermediates, supplying doxycycline APIs globally [2].
• HIKMA Pharmaceuticals (Jordan): A significant producer of doxycycline API, with supply chains stretching across the Middle East and internationally [3].
• Lupin Limited (India): A global generics manufacturer producing doxycycline API, often supplying pharmaceutical companies under licensing agreements [4].

These suppliers are subject to stringent quality standards to meet the regulatory requirements of markets such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The consistent quality and stability of doxycycline monohydrate are critical to ensure the efficacy and safety of Oracea.

Formulation and Contract Manufacturing Partners
While Galderma develops and owns Oracea, they often rely on Contract Manufacturing Organizations (CMOs) for the formulation, filling, and packaging of their products. These CMOs are typically located in North America and Europe, with capabilities for controlled-release drug formulations. Notable CMOs involved in such processes include:

• Hetero Labs Ltd. (India): Specialized in oral solid dose manufacturing with experience in controlled-release formulations.
• Patheon (part of Thermo Fisher Scientific): Provides comprehensive manufacturing services for complex pharmaceuticals, including sustained-release doxycycline capsules [5].

These partnerships ensure that the dosing form complies with the pharmacokinetic profile required for Oracea, which is typically a 40 mg delayed-release capsule.

Supply Chain Considerations and Raw Material Sourcing Challenges
The global doxycycline supply chain has faced disruptions, especially during the COVID-19 pandemic, impacting availability and pricing. Supply vulnerabilities can arise from:

• Regulatory hurdles: Import/export restrictions and quality compliance can delay shipments.
• Environmental factors: Climate-related events affecting manufacturing facilities or raw material supply.
• Market dynamics: Increased demand for antibiotics due to global health issues influences API prices and availability.

Given these complexities, pharmaceutical companies often diversify suppliers across regions to mitigate risks.

Distribution and Logistics Channels
Once manufactured, Oracea's distribution involves wholesale distributors, hospital pharmacies, and specialty pharmacies. Major distributors include McKesson, Cardinal Health, and AmerisourceBergen, which handle logistics across North America. For international markets, licensed wholesalers and regional distributors are engaged, complying with Good Distribution Practices (GDP).

Importantly, storage and handling protocols are critical to maintaining drug stability, especially considering Oracea’s specific packaging that preserves its controlled-release properties.

Regulatory and Patent Landscape
Oracea’s market presence is also influenced by patent protections and regulatory approvals. Though the patent exclusivity has expired or is nearing expiration in some jurisdictions, branding and formulation patents provide competitive barriers. Manufacturers must navigate evolving patent landscapes to establish supply agreements legally and effectively.

Emerging Suppliers and Generic Alternatives
The increasing availability of generic doxycycline formulations offers cost advantages but complicates supply chain oversight. Generic manufacturers sourcing doxycycline APIs from traditional suppliers like Lupin or HIKMA face regulatory scrutiny to ensure bioequivalence and quality. While generics are not branded as Oracea, they provide similar therapeutic benefits, expanding the supply landscape.

Conclusion
The supply chain for Oracea hinges on a complex interplay among specialized raw material suppliers, Contract Manufacturing Organizations, and distribution partners. The core API, doxycycline monohydrate, is sourced from established producers in India, the Middle East, and other regions, subjected to rigorous quality standards. Maintaining supply stability involves managing regulatory, environmental, and market volatility. For stakeholders, understanding these dynamics is vital for strategic planning, procurement, and market expansion.

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Key Takeaways

• Primary API Suppliers: Doxycycline monohydrate is mainly provided by companies including Lupin, HIKMA, and Hussain Daccus, primarily located in India and the Middle East.
• Manufacturing Partners: Specialized CMOs, especially in India and Europe, handle formulation, packaging, and controlled-release capsule manufacturing for Oracea.
• Supply Chain Risks: Disruptions through regulatory changes, geopolitical issues, or environmental factors require diversification of API sources.
• Regulatory Compliance: Ensuring API quality and manufacturing adherence to GMP standards is critical for maintaining product integrity and market approval.
• Market Dynamics: The expiration of patents and proliferation of generic doxycycline formulations influence supply chain strategies and pricing considerations.

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Frequently Asked Questions

1. Who are the main suppliers of doxycycline monohydrate used in Oracea?
Major suppliers include Lupin Limited (India), HIKMA Pharmaceuticals (Jordan), and Hussain Daccus Pharmaceutical (India). These companies produce doxycycline API that complies with international quality standards, suitable for controlled-release formulations like Oracea.

2. Can alternative suppliers produce the API without affecting Oracea’s quality?
Yes, provided these suppliers meet rigorous GMP standards and quality specifications. Transitioning suppliers requires comprehensive validation to ensure consistent bioavailability and safety profiles.

3. Are there regional differences in the supply chain of Oracea?
Yes. North America relies on domestic and North American CMOs, while international markets depend more heavily on Asian and Middle Eastern API suppliers, with regional distributors managing logistics.

4. How have recent global events impacted the supply chain for doxycycline API?
The COVID-19 pandemic and geopolitical tensions have disrupted manufacturing and logistics, leading to shortages and increased prices, prompting companies to diversify their supplier base.

5. Are generics a viable alternative to branded Oracea?
Generic doxycycline formulations can provide similar anti-inflammatory effects. However, they must meet strict bioequivalence and quality standards, and their availability depends on regional regulatory approvals.

Sources
[1] Galderma official website.
[2] Pharmaceutical Technology Asia. "Doxycycline API manufacturers: an overview."
[3] HIKMA Pharmaceuticals Annual Report 2022.
[4] Lupin Limited Annual Report 2022.
[5] Patheon service portfolio documentation.