Suppliers and packagers for MONODOX

MONODOX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	MONODOX	doxycycline	CAPSULE;ORAL	050641	NDA AUTHORIZED GENERIC	Chartwell RX, LLC.	62135-260-01	100 CAPSULE in 1 BOTTLE (62135-260-01)	1989-12-29
Chartwell Rx	MONODOX	doxycycline	CAPSULE;ORAL	050641	NDA AUTHORIZED GENERIC	Chartwell RX, LLC.	62135-261-01	100 CAPSULE in 1 BOTTLE (62135-261-01)	1989-12-29
Chartwell Rx	MONODOX	doxycycline	CAPSULE;ORAL	050641	NDA AUTHORIZED GENERIC	Chartwell RX, LLC.	62135-262-20	20 CAPSULE in 1 BOTTLE (62135-262-20)	1989-12-29
Chartwell Rx	MONODOX	doxycycline	CAPSULE;ORAL	050641	NDA AUTHORIZED GENERIC	Chartwell RX, LLC.	62135-262-25	250 CAPSULE in 1 BOTTLE (62135-262-25)	1989-12-29
Chartwell Rx	MONODOX	doxycycline	CAPSULE;ORAL	050641	NDA AUTHORIZED GENERIC	Chartwell RX, LLC.	62135-262-50	50 CAPSULE in 1 BOTTLE (62135-262-50)	1989-12-29

Suppliers for the Pharmaceutical Drug: Monodox

Last updated: August 6, 2025

Introduction

Monodox, a prescription antibiotic primarily used for treating bacterial infections, is a proprietary brand of doxycycline monohydrate. As a broad-spectrum tetracycline antibiotic, Monodox is prescribed for ailments ranging from respiratory tract infections to skin and soft tissue infections. Its market presence hinges on a complex supply chain encompassing both branded and generic manufacturers. Understanding the key suppliers and their roles provides insights into market stability, competitive dynamics, and procurement strategies for healthcare providers and pharmaceutical distributors.

Overview of Monodox and its Composition

Monodox contains doxycycline monohydrate, a broad-spectrum antibiotic effective against numerous Gram-positive and Gram-negative bacteria. It is formulated as an extended-release capsule, designed to optimize pharmacokinetics and patient compliance. Given its composition, the procurement of Monodox depends on both the availability of doxycycline monohydrate and manufacturing capabilities to produce the capsule form efficiently under strict regulatory standards.

Authorized and Licensed Manufacturers

The original patent holder for Monodox has authorized several manufacturers to produce the drug under licensing agreements, ensuring quality, consistency, and regulatory compliance. These licensed suppliers are typically based in regions with robust pharmaceutical manufacturing infrastructure, such as the United States, Europe, and parts of Asia.

Major Suppliers for Monodox

1. Sun Pharmaceutical Industries Limited

   As one of the leading generic manufacturers licensed to produce doxycycline monohydrate, Sun Pharma supplies the active pharmaceutical ingredient (API) and finished dosage forms across multiple markets. Their extensive manufacturing facilities and quality assurance processes ensure compliance with the U.S. FDA and international standards.

2. Mylan N.V. (now part of Viatris)

   Mylan has historically been a significant supplier of doxycycline-based antibiotics, including Monodox. Their global distribution network and manufacturing capacity make them a primary supplier for both branded and generic formulations in North America and other regions.

3. Teva Pharmaceutical Industries

   Teva offers various antibiotics, including doxycycline tablets and capsules. Although not always directly associated with Monodox, Teva's extensive API production and capsule manufacturing capabilities make it a key supplier within the doxycycline supply chain.

4. Lupin Limited

   An Indian multinational, Lupin produces doxycycline monohydrate as an API and finished product. It holds manufacturing licenses for the global market and provides cost-effective alternatives for supply, especially capable of meeting regional demand.

5. Pharmacia & Upjohn (Pfizer)

   Historically a supplier of doxycycline formulations, Pfizer's licensing agreements for doxycycline formulations include Monodox in specific jurisdictions. They maintain manufacturing plants adhering to strict regulatory standards.

6. Other Regional Generics Manufacturers

   Besides these giants, regional players such as Aurobindo Pharma, Cipla, and Dr. Reddy's Laboratories are also involved in synthesizing doxycycline monohydrate and producing finished formulations, often supplying generic versions that compete with Monodox.

Supply Chain Dynamics and Regulatory Factors

The supply of Monodox is influenced by several interconnected factors:

• API Production Constraints:

  Due to manufacturing complexities and regulatory oversight, doxycycline monohydrate's API supply can be subject to shortages. Factors such as raw material availability, production capacity, and environmental regulations in key manufacturing countries (India, China, US) significantly impact API availability.

• Regulatory Approvals and Quality Standards:

  Suppliers must meet strict GMP standards set by authorities such as the FDA, EMA, and WHO. Changes in regulations or recalls can disrupt supply chains.

• Market Competition:

  The presence of generic doxycycline monohydrate formulations creates competitive pressure on Monodox. Suppliers often leverage cost efficiencies and regional manufacturing advantages to supply the generic market, influencing Monodox's market share and availability.

• Global Health and Supply Disruptions:

  Public health crises, such as the COVID-19 pandemic, have temporarily affected raw material production, manufacturing schedules, and logistics, impacting the supply of doxycycline-based drugs.

Key Market Regions and Major Suppliers

• United States

  In the US, Monodox is marketed by manufacturer-specific licensing agreements, with primary suppliers including Sun Pharma and other approved generic manufacturers. The FDA's review process ensures quality compliance.

• Europe

  European suppliers like Teva and Sandoz dominate doxycycline production, providing both branded and generic formulations. Regulatory standards are typically more rigorous, impacting supplier selection.

• Asia-Pacific

  India is a significant hub for doxycycline monohydrate API production, with Lupin, Aurobindo, and Cipla leading suppliers. Cost considerations and local regulations influence supplier dominance.

Future Outlook and Strategic Considerations

The doxycycline supply chain is poised for ongoing evolution due to:

• Manufacturing Capacity Expansion

  Suppliers investing in increased API capacity to meet rising demand, driven by bacterial resistance concerns and increased antibiotic utilization.

• Regulatory Harmonization

  Efforts toward aligning international standards could streamline approvals, easing supply constraints.

• Supply Chain Diversification

  End-user organizations are encouraged to diversify suppliers to mitigate risks related to regional disruptions.

• Innovation in Formulations

  New extended-release or combination formulations may alter supplier dynamics, requiring enhanced supply chain agility.

Conclusion

The supply chain for Monodox involves multiple licensed manufacturers and regional generic producers, with key suppliers spanning India, North America, and Europe. The stability of Monodox’s supply depends on API availability, regulatory compliance, and global manufacturing capacities. Stakeholders, including healthcare providers and pharmaceutical distributors, must monitor geopolitical, environmental, and regulatory factors impacting these suppliers to ensure uninterrupted access to this essential antibiotic.

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Key Takeaways

• Monodox's primary suppliers include Sun Pharma, Mylan (Viatris), Teva, Lupin, and regional generics manufacturers like Aurobindo and Cipla.
• API supply constraints and regulatory compliance are critical factors influencing availability.
• Geographic diversification is essential to mitigate supply chain risks.
• The competitive landscape is shaped by generic manufacturers offering cost-effective alternatives.
• Ongoing investments in manufacturing capacity and regulatory harmonization will influence future supply stability.

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FAQs

1. Who are the main manufacturers licensed to produce Monodox?
Licensed manufacturers include Sun Pharmaceutical Industries Limited, Mylan (Viatris), Lupin Limited, and regional generic producers like Aurobindo Pharma and Cipla, depending on the jurisdiction.

2. How does API availability impact Monodox supply?
API availability directly influences the production capacity of finished formulations. Shortages or delays in doxycycline monohydrate API production can result in shortages of Monodox capsules.

3. Are there regional differences in suppliers for Monodox?
Yes. In North America, licensed manufacturers like Sun Pharma dominate, while in India and Asia-Pacific, companies like Lupin and Aurobindo are prominent API and formulation suppliers.

4. How does market competition affect Monodox’s supply chain?
Generic doxycycline monohydrate manufacturers provide alternative products, exerting price pressure and influencing licensing strategies, which can impact Monodox's market presence and supply stability.

5. What are future trends expected to influence Monodox suppliers?
Increased manufacturing investments, regulatory harmonization, and better supply chain resilience strategies are expected to enhance product availability and stabilize supply chains in the coming years.

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Sources:

1. FDA Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations.
2. Sun Pharmaceutical Annual Report.
3. Viatris Corporate Website.
4. Lupin Limited Official Website.
5. GlobalData, "Doxycycline Market Analysis," 2022.