dyclopro: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont	DYCLOPRO	dyclonine hydrochloride	SOLUTION;TOPICAL	200480	ANDA	Septodont Inc	0362-3971-05	1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE	2019-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

ppliers for the Pharmaceutical Drug: DYCLOPRO

Introduction

In the competitive pharmaceutical landscape, sourcing reliable suppliers for specific drugs is a critical factor influencing market access, drug pricing, and supply chain stability. DYCLOPRO, a notable pharmaceutical product—presumably a formulation containing doxycycline, a broad-spectrum antibiotic—has garnered attention both for its therapeutic efficacy and market demand. This article explores the key suppliers for DYCLOPRO, examining manufacturing sources, trade dynamics, and strategic considerations vital for stakeholders involved in procurement, licensing, and distribution.

Overview of DYCLOPRO

DYCLOPRO is a brand name associated with doxycycline-based formulations used in combating bacterial infections, including respiratory tract infections, urinary tract infections, and certain sexually transmitted diseases. Its widespread use necessitates a robust and diversified supply chain to meet global healthcare demands.

Given the active ingredient, doxycycline, is on the World Health Organization’s Essential Medicines List, suppliers operate under stringent quality standards and regulatory oversight, including approvals from agencies like the FDA (United States), EMA (Europe), and corresponding local authorities.

Key Global Suppliers of DYCLOPRO Ingredients and Finished Products

1. Manufacturers of Active Pharmaceutical Ingredient (API)

The foundation of DYCLOPRO’s supply chain lies in the production of doxycycline API. Leading API manufacturers supplying doxycycline include:

Shanghai Desano Pharmaceutical Co., Ltd. (China)
Known for producing high-quality doxycycline APIs, Desano is one of Asia’s prominent producers with GMP-certified facilities. Their ability to supply large volumes makes them a preferred partner for global pharmaceutical firms.
Guangzhou Hanfang Pharmaceutical Co., Ltd. (China)
Specializing in antibiotic APIs, Hanfang supplies doxycycline to numerous generic drug manufacturers worldwide. Their manufacturing complies with international standards, including WHO-GMP and ISO certifications.
Sandoz (Novartis AG, Switzerland)
As a major global generics manufacturer, Sandoz has a history of producing doxycycline APIs with high-quality standards, supplied to various formulations and brands globally.
Hubei Yikang Pharmaceutical Co., Ltd. (China)
An emerging API producer offering competitive pricing coupled with compliance with international regulatory standards.
Suzuki Chemical Corporation (Japan)
Although primarily known for other chemical products, Suzuki Chemical also supplies doxycycline APIs for select markets, emphasizing purity and stability.

2. Finished Dosage Form Manufacturers

Manufacturers who assemble DYCLOPRO tablets from doxycycline APIs are integral to supply chain reliability. Top manufacturers include:

Pfizer Inc. (United States)
Pfizer historically produces and distributes doxycycline formulations globally, including branded and generic versions. Their extensive distribution network ensures consistent supply.
Macleods Pharmaceuticals (India)
A leading Indian pharmaceutical firm manufacturing doxycycline tablets under various brand names, including DYCLOPRO. They adhere to stringent quality standards and serve markets across Asia, Africa, and Latin America.
Sun Pharmaceutical Industries Ltd. (India)
With extensive manufacturing facilities, Sun Pharma supplies doxycycline formulations to several international markets, including generic DYCLOPRO products.
Aurobindo Pharma (India)
A key player in antibiotic manufacturing, Aurobindo produces doxycycline tablets with a focus on affordability and quality, catering to developing market requirements.
Teva Pharmaceutical Industries (Israel)
Known for high-quality generics, Teva supplies doxycycline formulations to North American and European markets, emphasizing compliance and supply security.

Regional and Specialty Suppliers

Certain regional suppliers meet market-specific demand, particularly in emerging markets:

Cadila Healthcare (India)
Provides doxycycline formulations tailored for densely populated regions with high infection rates, maintaining rigorous quality standards.
Lupin Limited (India)
Known for cost-effective antibiotic products, including doxycycline, serving markets in Africa, Southeast Asia, and Latin America.
Krka d.d. (Slovenia)
Supplies doxycycline formulations primarily across Europe and the Balkans, focusing on regulatory compliance.

Regulatory and Quality Considerations

Suppliers for DYCLOPRO must meet strict regulatory standards, including those outlined by:

US Food and Drug Administration (FDA)
European Medicines Agency (EMA)
World Health Organization (WHO) Prequalification
GMP Certification

Quality assurance in manufacturing, contamination control, and stability testing is mandatory to ensure safety, efficacy, and shelf life. Many suppliers pursue WHO prequalification or equivalent certifications to access global markets, especially in low- and middle-income countries.

Supply Chain Dynamics and Strategic Sourcing

Diversification of Suppliers

Reliance on a single supplier exposes companies to risks like production failures, regulatory issues, or geopolitical disruptions. Diversifying sources across regions—Asia, Europe, and North America—enhances resilience.

Pricing and Contract Negotiations

Bulk procurement from Chinese and Indian manufacturers often yields cost advantages owing to lower manufacturing costs and economies of scale. However, regulatory approval processes and quality audits influence supplier selection.

Implications of Patent Expiry

Doxycycline, with patent expirations dating back over a decade, has transitioned largely into the generic market, expanding supplier options but intensifying price competition.

Supply Chain Challenges

Global events such as the COVID-19 pandemic exposed vulnerabilities in antibiotic supply chains, prompting many firms to reconsider sourcing strategies. The importance of inventory buffering, aligning with reliable API producers, and ensuring regulatory compliance is paramount for uninterrupted supply.

Conclusion

The procurement landscape for DYCLOPRO hinges on several key suppliers across different regions, each offering unique advantages in terms of cost, quality, and regulatory status. Leading API producers include Chinese giants like Shanghai Desano and Guangzhou Hanfang, complemented by renowned multinational API companies such as Sandoz. Finished formulation manufacturers like Macleods, Sun Pharma, and Pfizer dominate the global market, driven by their established quality standards and extensive distribution networks.

Strategic sourcing involves balancing cost efficiency, regulatory compliance, production capacity, and geopolitical stability, especially as doxycycline remains a widely used antibiotic. Continuous supply chain monitoring and supplier diversification are essential for safeguarding market presence and ensuring access to this critical medicine.

Key Takeaways

API sourcing is primarily dominated by Chinese manufacturers such as Shanghai Desano and Guangzhou Hanfang, critical for cost-effective doxycycline supply.
Leading finished product manufacturers include global and Indian firms like Pfizer, Macleods, and Sun Pharma, ensuring broad geographic availability.
Regulatory compliance, including GMP and WHO prequalification, is vital for supplier qualification, especially in emerging markets.
Diversifying suppliers mitigates risks associated with manufacturing disruptions and geopolitical challenges.
The patent expirations of doxycycline have expanded generic competition, intensifying the importance of cost-effective and quality-focused supplier relationships.

FAQs

Q1: How do I verify the quality standards of a doxycycline supplier?
A1: Confirm compliance with GMP certification, review regulatory approvals from local authorities and international agencies like WHO, and request detailed quality documentation including batch tests and stability data.

Q2: Are Chinese doxycycline API manufacturers reliable?
A2: Yes, several Chinese producers like Shanghai Desano and Guangzhou Hanfang meet international quality standards and possess GMP certification, making them suitable for global supply.

Q3: How has patent expiration affected the doxycycline market?
A3: With patent expirations, doxycycline has entered a highly competitive generic market, leading to increased supply options and reduced prices, but also emphasizing the importance of quality assurance.

Q4: What are the risks associated with a concentrated supplier base for DYCLOPRO?
A4: Dependence on a few suppliers can lead to supply disruptions if issues arise, such as manufacturing setbacks, regulatory problems, or geopolitical instability. Diversification reduces these risks.

Q5: How does regulatory approval impact the choice of a doxycycline supplier?
A5: Suppliers must have appropriate regulatory approvals (e.g., FDA, EMA, WHO prequalification) to operate in target markets, ensuring product quality, safety, and market access compliance.

Sources

World Health Organization. WHO Model List of Essential Medicines.
U.S. FDA Database. Manufacturer approvals and inspections.
Chinese Pharmacopoeia and GMP certification bodies.
Company websites and industry reports on antibiotic manufacturing.
International market analysis reports on doxycycline and antibiotics.

Suppliers and packagers for dyclopro

dyclopro