tetracycline hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avet	ACHROMYCIN V	tetracycline hydrochloride	CAPSULE;ORAL	050278	NDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-017-01	100 CAPSULE in 1 BOTTLE (23155-017-01)	2024-09-15
Avet	ACHROMYCIN V	tetracycline hydrochloride	CAPSULE;ORAL	050278	NDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-018-01	100 CAPSULE in 1 BOTTLE (23155-018-01)	2024-09-15
Amneal Pharms Ny	TETRACYCLINE HYDROCHLORIDE	tetracycline hydrochloride	CAPSULE;ORAL	210674	ANDA	Amneal Pharmaceuticals NY LLC	60219-1522-1	100 CAPSULE in 1 BOTTLE (60219-1522-1)	2022-08-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Tetracycline hydrochloride is a broad-spectrum antibiotic widely used in clinical settings to treat bacterial infections. Its efficacy depends on high-quality raw materials supplied by reputable manufacturers. The global supply chain for tetracycline hydrochloride involves several key players, primarily located in regions with established pharmaceutical manufacturing infrastructure. This article provides a comprehensive overview of the leading suppliers, their market positions, and factors influencing procurement decisions.

Overview of Tetracycline Hydrochloride

Tetracycline hydrochloride is a bacteriostatic antibiotic first discovered in the 1940s, belonging to the tetracycline class of antibiotics. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, making it effective against various gram-positive and gram-negative pathogens. Its production involves complex chemical synthesis or fermentation processes, necessitating precise quality controls from raw material to final product.

Key Suppliers by Region

1. China

China remains the dominant supplier of tetracycline hydrochloride globally, accounting for a significant share of production volume. Major Chinese pharmaceutical manufacturers specialized in antibiotic synthesis include:

Hengkang Pharmaceutical Co., Ltd.
Recognized for producing high-quality tetracycline intermediates and active pharmaceutical ingredients (APIs), Hengkang adheres to cGMP standards, serving both domestic and international markets.
Shandong Xinhua Pharmaceutical Company
One of the largest producers of tetracycline and its derivatives, with extensive capacity, primarily supplying Asia-Pacific and exporting to markets in Africa, Latin America, and emerging regions.
Jiangxi Huayu Pharmaceutical Co., Ltd.
Focused on tetracycline and related antibiotics, this manufacturer specializes in high-purity tetracycline hydrochloride for both pharmaceutical and feed additive applications.

2. India

India hosts several pharmaceutical companies involved in the production of tetracycline hydrochloride, often leveraging cost advantages and robust manufacturing infrastructure:

S.M. Scientific Works Pvt. Ltd.
Engaged in making tetracycline APIs, they fulfill domestic demand and export to various continents, with ISO certifications ensuring quality standards.
Maneesh Pharmaceuticals Ltd.
Known for manufacturing tetracycline hydrochloride with strict compliance to international quality certifications (e.g., WHO-GMP).

3. Europe & North America

While less dominant in volume, suppliers in Europe and North America often focus on premium, high-purity formulations catering to stringent regulatory environments:

Sigma-Aldrich / Merck Group (Germany)
Supplies research-grade tetracycline hydrochloride for laboratory and clinical research purposes, with some commercial-grade APIs available through dedicated partnerships.
Pfizer Inc. (United States)
Historically involved in antibiotic manufacturing, Pfizer has or had capabilities in producing tetracycline derivatives, though much of their supply is now outsourced or discontinued.

Third-Party Contract Manufacturing and API Suppliers

In addition to direct manufacturers, several contract manufacturing organizations (CMOs) supply tetracycline hydrochloride under strict quality agreements:

Hubei Hu boa Pharma Co., Ltd. (China)
Offers custom synthesis and bulk APIs with an emphasis on quality control and regulatory compliance.
CordenPharma (Germany)
Provides tailored manufacturing and API development services, including antibiotic APIs like tetracycline hydrochloride.
Hunan Er-Kang Pharmaceutical Co., Ltd.
Focused on antimicrobial APIs, offering cost-effective options suitable for both human and veterinary applications.

Factors Influencing Supplier Choice

Selecting an appropriate supplier depends on several critical factors:

Regulatory Compliance: Certification standards such as cGMP, EPA, WHO-GMP, and FDA approval influence supplier selection.
Product Quality: Purity, particle size, stability, and absence of contaminants are critical criteria.
Supply Chain Reliability: Consistent production capacity, adherence to delivery schedules, and contingency planning are vital.
Cost Efficiency: Competitive pricing, especially for large-volume procurement, impacts overall operational costs.
Geopolitical and Trade Considerations: Tariffs, import/export restrictions, and political stability affect sourcing strategies.

Emerging Trends and Market Dynamics

The global tetracycline hydrochloride market faces challenges, including regulatory scrutiny of antibiotic residues, environmental concerns regarding antibiotic manufacturing waste, and increasing antimicrobial resistance. Consequently, suppliers are investing in greener synthesis methods and rigorous quality assurance. Additionally, the COVID-19 pandemic has disrupted supply chains, prompting buyers to diversify suppliers and regions.

Conclusion: Ensuring Reliable Procurement

For pharmaceutical companies, sourcing tetracycline hydrochloride involves balancing quality, cost, and supply chain resilience. Chinese manufacturers dominate the market with large production capacities, but quality assurance remains paramount. India offers cost-competitive options, with European and North American suppliers emphasizing high purity and regulatory compliance. As market dynamics evolve, building relationships with multiple reputable suppliers and maintaining strict quality control are essential strategies.

Key Takeaways

China leads global tetracycline hydrochloride production, with numerous certified manufacturers serving international markets.
Indian pharmaceutical companies provide cost-effective alternatives, with growing capacities and export capabilities.
European and North American suppliers primarily focus on high-purity APIs suitable for regulated markets.
Contract manufacturing organizations (CMOs) offer customized solutions and support supply chain diversification.
Regulatory compliance, quality assurance, and supply chain resilience are critical criteria when selecting suppliers.

FAQs

1. What are the main regions supplying tetracycline hydrochloride globally?
China is the predominant supplier, followed by India and specialized providers in Europe and North America.

2. How does regulatory compliance impact supplier selection?
Suppliers with certifications like cGMP, WHO-GMP, and FDA approval ensure quality and facilitate smoother regulatory approval processes in target markets.

3. Are there high-quality alternatives to Chinese tetracycline hydrochloride?
Yes, European and North American suppliers provide high-purity APIs, often used in stringent regulatory environments, though at a higher cost.

4. What considerations should companies make regarding supply chain security?
Diversification of suppliers across regions, maintaining buffer inventories, and establishing long-term agreements minimize supply disruptions.

5. How are environmental concerns affecting tetracycline hydrochloride manufacturing?
Manufacturers are adopting greener synthesis processes, reducing waste and emissions, aligning with global sustainability initiatives.

Sources:

[1] Market research reports on antibiotic APIs.
[2] Official certifications from Chinese and Indian pharmaceutical regulators.
[3] Company websites and annual reports.
[4] Industry publications on pharmaceutical manufacturing standards.

Suppliers and packagers for generic pharmaceutical drug: tetracycline hydrochloride