Suppliers and packagers for ACTICLATE CAP

ACTICLATE CAP

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	ACTICLATE CAP	doxycycline hyclate	CAPSULE;ORAL	208253	NDA	Aqua Pharmaceuticals	16110-601-01	60 CAPSULE in 1 BOTTLE (16110-601-01)	2018-05-31
Chartwell Rx	ACTICLATE CAP	doxycycline hyclate	CAPSULE;ORAL	208253	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-975-20	20 CAPSULE in 1 BOTTLE (62135-975-20)	2016-04-26

Suppliers for the Pharmaceutical Drug: ACTICLATE CAP

Last updated: August 6, 2025

Introduction

ACTICLATE CAP, commonly recognized under the generic name Clindamycin Capsules, is a widely prescribed antibiotic used to treat various bacterial infections. Its efficacy against anaerobic bacteria and certain protozoal infections has cemented its role in clinical practice. As a pivotal therapeutic agent, understanding its suppliers, manufacturing landscape, and supply chain dynamics is crucial for healthcare providers, pharmaceutical companies, and policy-makers aiming to ensure uninterrupted access. This comprehensive analysis explores the primary suppliers of ACTICLATE CAP, including manufacturing companies, geographic distribution, regulatory status, and market considerations.

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Overview of ACTICLATE CAP Manufacturing Landscape

Clindamycin, the active pharmaceutical ingredient (API) in ACTICLATE CAP, is synthesized by numerous pharmaceutical manufacturers across the globe. While the finished dosage form (the capsules) is produced by various pharmaceutical companies, the key focus for market stability lies in the suppliers of the API, bulk intermediates, and finished formulations. The supply chain encompasses both originator (branded) and generic manufacturers who cater to a global demand.

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Major API Suppliers for ACTICLATE CAP

1. Mylan (now part of Viatris)

Mylan has historically been a significant supplier of clindamycin API. Their manufacturing facilities, located in India and the United States, produce high-quality APIs distributed globally. Mylan’s extensive supply chain expertise ensures consistent API production, facilitating the widespread availability of generic clindamycin products, including ACTICLATE CAP.

2. Teva Pharmaceuticals

Teva is one of the largest generic pharmaceutical producers worldwide. With manufacturing units in Israel, India, and Europe, Teva supplies clindamycin APIs to multiple markets. Their robust global network ensures supply continuity and compliance with international regulatory standards.

3. Hikma Pharmaceuticals

Hikma, based in Jordan and with manufacturing facilities across Europe and the Middle East, is a prominent supplier of clindamycin API. They produce both raw materials and finished formulations, making them a critical player in supply chains for ACTICLATE CAP.

4. Micro Labs

India-based Micro Labs produces API and finished formulations of clindamycin. Their manufacturing plants are WHO-GMP certified, and they extensively export to North America, Europe, and Asia, contributing significantly to global supplies.

5. Akorn (acquired by Fresenius Kabi)

Although primarily known for finished formulations, Akorn has historically supplied clindamycin capsules, backed by API sourcing from multiple manufacturers. Their global distribution channels reinforce the availability of ACTICLATE CAP in various markets.

Key Manufacturers in India and China

India remains a dominant hub for the manufacture of generic antibiotics like clindamycin, with several firms offering high-quality APIs and finished products:

• Lupin Limited
• Sun Pharma
• Aurobindo Pharma
• Dr. Reddy’s Laboratories

Similarly, Chinese manufacturers such as Zhejiang Huahai Pharmaceutical and Shanghai Saike Biotechnology have expanded their API capabilities, including antibiotics like clindamycin, driven by competitive pricing and growing export markets.

Regulatory and Quality Considerations

Suppliers must adhere to good manufacturing practices (GMP) validated by international regulators such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). High-quality manufacturing ensures API safety, efficacy, and supply stability, which influences the choice of suppliers for global markets.

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Market Dynamics and Supply Chain Considerations

The supply landscape for ACTICLATE CAP is shaped by factors such as:

• Regulatory approvals and compliance: Only manufacturers with approved facilities and quality certifications can supply to markets like the U.S., Europe, and Japan.
• Manufacturing capacity: Increased demand during the COVID-19 pandemic underscored the importance of scalable production capabilities.
• Pricing pressures: Generic manufacturers often compete through cost-effective production, mainly in India and China.
• Supply chain disruptions: Political, logistical, and regulatory challenges can impact API availability, emphasizing the reliance on diversified supply sources.

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Distribution and Secondary Suppliers

Finished ACTICLATE CAP products are distributed globally through a network of regional and local pharmaceutical distributors. Major pharmaceutical companies manufacturing ACTICLATE CAP include:

• Pfizer (original brand; now generic distribution)
• Mylan/Viatris
• Teva
• Hikma

These companies often source their APIs from primary API manufacturers or contract manufacturing organizations (CMOs).

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Future Outlook

The global demand for ACTICLATE CAP is expected to grow, driven by antibiotic resistance persistence and expanded indications. Suppliers investing in capacity expansion and ensuring strict regulatory compliance will likely maintain their market positions. Additionally, emerging markets may see increased participation of local manufacturers, diversifying the supply chain further.

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Conclusion

The supply chain for ACTICLATE CAP is robust, with multiple reputable manufacturers spanning India, China, Europe, and North America. Key API suppliers include Viatris (formerly Mylan), Teva, Hikma, Micro Labs, and Chinese firms, all adhering to stringent quality standards. Healthcare stakeholders must monitor geopolitical and regulatory developments that could influence the availability and pricing of ACTICLATE CAP. Ensuring diversified procurement sources and maintaining compliance will be critical in preventing shortages and supporting global demand.

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Key Takeaways

• Multiple reputable API manufacturers supply clindamycin for ACTICLATE CAP, with India and China leading production hubs.
• Regulatory compliance (FDA, EMA, WHO-GMP) is critical for supply chain integrity, especially in export markets.
• Market dynamics, including capacity expansion and geopolitical factors, influence supply stability.
• Diversifying suppliers reduces risks of shortages and price volatility.
• Monitoring supply chain developments and engaging with authorized distributors enhances procurement security.

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FAQs

1. Who are the leading API manufacturers for ACTICLATE CAP?
India-based companies like Micro Labs, Aurobindo Pharma, and Sun Pharma, as well as Chinese firms such as Zhejiang Huahai Pharmaceutical, are key API suppliers conforming to international quality standards.

2. Are generic manufacturers reliably supplying ACTICLATE CAP globally?
Yes. Major generic manufacturers with GMP-certified facilities, including Viatris (Mylan), Teva, and Hikma, have established reliable supply chains, although disruptions can occur due to geopolitical or logistical issues.

3. How does regulatory approval impact the suppliers of ACTICLATE CAP?
Regulatory approvals ensure manufacturers meet quality and safety standards, enabling their products to be marketed internationally. Non-compliant manufacturers may be restricted, affecting global supply.

4. What are the risks to the supply chain for ACTICLATE CAP?
Risks include manufacturing disruptions, political instability, changes in regulations, and logistical delays, especially in reliance on API production in India and China.

5. What future trends could influence ACTICLATE CAP supply?
Growing antibiotic resistance, increased demand, capacity expansion by key manufacturers, and shifts in geopolitical landscapes will shape supply stability and market pricing.

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Sources

1. [1] U.S. Food and Drug Administration (FDA). Approved Drug Products.
2. [2] European Medicines Agency (EMA). Medicine Information.
3. [3] IQVIA. Global Pharmaceutical Industry Reports.
4. [4] Pharmaceutical Business Insights – Market Reports.
5. [5] Company Websites: Viatris, Teva, Hikma, Micro Labs.