ACTICLATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	ACTICLATE	doxycycline hyclate	TABLET;ORAL	205931	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-907-20	20 TABLET, FILM COATED in 1 BOTTLE (62135-907-20)	2014-07-25
Chartwell Rx	ACTICLATE	doxycycline hyclate	TABLET;ORAL	205931	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-908-20	20 TABLET, FILM COATED in 1 BOTTLE (62135-908-20)	2014-07-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 9, 2025

Introduction

The pharmaceutical landscape for antibiotics has evolved significantly over recent decades, driven by the imperative to combat resistant infections and improve treatment outcomes. Among these antibiotics, Acticlate, a brand name for doxycycline hyclate, plays a notable role in managing bacterial infections, including respiratory tract infections, Lyme disease, and acne. Given its widespread use, identifying reliable suppliers of Acticlate is crucial for healthcare providers, pharmacists, and distributors to ensure consistent supply, quality, and compliance with regulations.

Overview of Acticlate (Doxycycline Hyclate)

Acticlate is a doxycycline hyclate formulation, a broad-spectrum tetracycline antibiotic. It functions by inhibiting bacterial protein synthesis via binding to the 30S ribosomal subunit, exhibiting activity against various Gram-positive and Gram-negative bacteria. Its formulations typically include capsules, tablets, and suspensions, used both clinically and in outpatient settings. The drug is off-patent, introducing multiple manufacturing and distribution options worldwide.

Manufacturers and Primary Suppliers

1. Original Brand Manufacturers

While Acticlate itself is a brand-specific formulation, its active pharmaceutical ingredient (API), doxycycline hyclate, originates from several pharmaceutical companies that produce both generic and brand-name versions.

Pfizer Inc.
Historically, Pfizer has been a prominent producer and distributor of doxycycline in various formulations, including intravenous and oral forms. Pfizer's extensive global infrastructure ensures broad availability, although Pfizer primarily supplies to large distributors and institutional buyers.
Adams Chemical and Pharmaceutical Co.
A U.S.-based manufacturer specializing in antibiotics, including doxycycline hyclate, often supplying formulations for generics and private-label brands.

2. Generic Manufacturers

Multiple pharmaceutical companies manufacture doxycycline hyclate as a generic API, which is subsequently formulated into Acticlate or similar products by various drug makers:

Serum Institute of India
A major producer of antibiotics, including doxycycline hyclate, exporting globally. Their products often supply generic markets and private-label formulations.
Aurobindo Pharma
An India-based pharmaceutical company with a significant portfolio of antibiotics, including doxycycline hyclate, distributed worldwide through various channels.
Macleods Pharmaceuticals
Known for producing high-quality generic antibiotics, including doxycycline hyclate, with compliance to international standards.
Sagent Pharmaceuticals
Specializes in injectable and oral antibiotics, including doxycycline formulations for hospital and outpatient settings.
Sun Pharmaceutical Industries
A global leader in generics, Sun Pharma manufactures doxycycline hyclate as part of its extensive antibiotic portfolio.
Teva Pharmaceutical Industries
A leading generic drug manufacturer offering doxycycline hyclate in multiple forms, often supplying to U.S. and global markets.

Distribution and Supply Chains

The supply chain for Acticlate hinges on the distribution of its API, as well as the final formulation. These are typically sourced from:

API Manufacturers: Supplying doxycycline hyclate to pharmaceutical formulators lasting from the raw material suppliers to finished product manufacturers.
Pharmaceutical Distributors and Wholesalers: Entities such as AmerisourceBergen, McKesson, and Cardinal Health in the U.S., and health authorities globally, distribute Acticlate and its generics.
Private Label and Contract Manufacturers: Many companies produce doxycycline hyclate capsules under private labels for hospitals, clinics, or pharmacy chains.

Qualities to Consider in Suppliers

When selecting suppliers for Acticlate or doxycycline hyclate API, key factors include:

Regulatory Compliance: Certificates of Good Manufacturing Practice (GMP), ISO certifications, and compliance with the FDA, EMA, or other regional regulatory authorities.
Product Quality and Purity: Evidence of rigorous testing, batch consistency, and stability data.
Supply Reliability: Ability to meet demand fluctuations, particularly during shortages or global health emergencies.
Pricing and Contract Terms: Competitive pricing aligned with quality standards and long-term supply agreements.

Global Market Dynamics

The global antibiotic market faces challenges such as:

Regulatory Harmonization: Ensuring API and finished product compliance across countries, especially with stricter quality controls.
Antimicrobial Resistance (AMR): Impacting demand patterns and prompting manufacturers to refine formulations and supply security.
Pandemic Impact: COVID-19 highlighted vulnerabilities in supply chain logistics, emphasizing the importance of diversified sourcing.

Key Suppliers and Considerations

Supplier	Region	Certifications	Notes
Pfizer Inc.	Global	FDA, EMA	Large-scale production, primarily branded supply
Aurobindo Pharma	India	GMP, USFDA, EMA	Cost-effective, high-quality generics
Sun Pharmaceutical	India/Global	GMP, USFDA, EMA	Wide distribution network
Teva Pharmaceutical	Israel/Global	GMP, USFDA	Extensive generic antibiotic portfolio
Sagent Pharmaceuticals	U.S.	FDA, cGMP	Specialized in hospital-grade formulations
Macleods Pharmaceuticals	India	GMP, USFDA	High-quality manufacturing, expanding international footprint

Regulatory and Compliance Implications

Suppliers must consistently meet stringent regulatory standards to prevent supply disruptions and ensure patient safety. Manufacturers authorized by the FDA (U.S.), EMA (Europe), and other authorities are preferred. It is advisable for buyers to verify Certificates of Analysis (CoA), stability data, and inspection reports before procurement.

Conclusion

The landscape of Acticlate supply is characterized by diverse manufacturers spanning the US, India, Europe, and other regions. While Pfizer maintains historical prominence in antibiotic production, many generics manufacturers, including Aurobindo, Sun Pharma, and Teva, are key contributors to global supply. Ensuring high-quality, compliant, and reliable sourcing requires strategic partnerships with verified suppliers possessing robust quality assurance protocols.

Key Takeaways

Diversify sourcing: To mitigate supply risks, engage multiple certified suppliers for doxycycline hyclate, the API used for Acticlate.
Prioritize compliance: Work with suppliers holding GMP and regulatory approvals to ensure safety and quality.
Monitor market dynamics: Stay informed about global antibiotic demand, regulatory changes, and potential shortages.
Negotiate favorable contracts: Secure competitive pricing and supply commitments aligned with clinical demand.
Verify documentation: Always review Certificates of Analysis and regulatory compliance certificates before procurement.

FAQs

What are the main regions supplying doxycycline hyclate for Acticlate production?
Primarily India, the United States, Europe, and Israel, with leading manufacturers like Aurobindo, Teva, and Sun Pharma.
How can buyers verify the quality of doxycycline hyclate suppliers?
By reviewing GMP and ISO certifications, requesting Certificates of Analysis, and conducting supplier audits.
Are there any emerging suppliers for Acticlate?
Yes; several regional manufacturers in Asia and Eastern Europe are expanding their antibiotic portfolios, subject to regulatory approval.
What are the risks associated with relying on a single supplier?
Supply disruptions, quality issues, price volatility, and regulatory non-compliance risks.
How does regulatory compliance impact the supply of Acticlate?
Suppliers compliant with regional standards (FDA, EMA, MHRA) ensure product safety, facilitate import/export, and reduce legal risks.

References

U.S. Food and Drug Administration (FDA). Approved drug products with therapeutic equivalence evaluations.
European Medicines Agency (EMA). Approved medicines database.
Pharmaceutical Market Reports. Global Antibiotics Market Overview, 2022.
Supplier Websites and Certification Documents.
World Health Organization (WHO). Antimicrobial resistance global report, 2021.

Suppliers and packagers for ACTICLATE

ACTICLATE

Suppliers for the Pharmaceutical Drug: Acticlate