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Last Updated: March 26, 2026

Suppliers and packagers for ACTICLATE CAP


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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
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for ACTICLATE CAP

Last updated: February 20, 2026

ACTICLATE CAP (clindamycin phosphate capsules) is an antibiotic used to treat bacterial infections. Its supply chain includes several global and regional manufacturers.

Major Manufacturers and Suppliers

Company Name Country API Production Capsule Manufacturing Market Presence Notes
Pfizer Inc. United States Yes Yes Global, with primary markets in North America and Europe Original patent holder; brands include Cleocin.
Sun Pharmaceutical Industries India API and Formulation Capsule production Strong presence in India, Africa, Asia Manufactures generic versions of clindamycin.
Teva Pharmaceutical Industries Israel API and Formulation Capsule production Global, particularly in North America and Europe Produces generic clindamycin capsules.
Cipla Ltd. India API and Formulation Capsule production Major supplier in Asia, Africa, and Latin America Known for affordable generics.
Mylan N.V. (now part of Viatris) Netherlands API and Formulation Capsule production Wide global distribution, including US, Europe Provides generic clindamycin capsules.
Dr. Reddy’s Laboratories India API and Formulation Capsule production Focused on emerging markets Supplies both API and finished formulations.

API Production and Sales

Most API production occurs in India and Israel, with some companies in Europe and North America. API quality standards align with USP and EP regulations, crucial for regulatory approval.

Capsule Manufacturing

Manufacturing of capsules is handled by companies either vertically integrated or through third-party contract manufacturing organizations (CMOs). Quality certifications include GMP compliance, ISO standards, and country-specific regulations.

Regulatory and Market Access

Suppliers must navigate complex regulatory environments. Successful registration typically requires:

  • Good Manufacturing Practice (GMP) certification.
  • Submission of stability data.
  • Patent and exclusivity considerations; patent expiry generally occurs around 2014-2019, leading to a proliferation of generics.

Market Dynamics

  • Patent expiration spurred a surge in generic suppliers.
  • Price competition drives down costs, influencing procurement strategies.
  • Supply chain disruptions can arise from geopolitical issues, raw material shortages, or regulatory delays.

Key Regional Suppliers

  • India: Leading producer of both API and finished capsules; low-cost manufacturing advantage.
  • Europe & North America: Focus on quality control, regulations, and brand-specific formulations.
  • Emerging Markets: Significant demand due to affordability and local manufacturing.

Industry Trends

  • Increasing use of contract manufacturing.
  • Emphasis on API quality and compliance.
  • Growth in generic market share post-patent expiry.

Notes on Procurement

  • Due diligence on supplier GMP compliance is essential.
  • Capacity and lead times vary significantly.
  • Sourcing from multiple suppliers mitigates risk.

Final Remarks

Suppliers are predominantly based in India, Europe, and Israel. Pfizer remains the original innovator, while generic manufacturers dominate current supply, especially post-patent expiry.

Key Takeaways

  • Multiple global suppliers produce ACTICLATE CAP, with a concentration in India.
  • Quality standards align with international regulatory requirements.
  • Market dynamics favor low-cost generic manufacturers.
  • Supply chain stability relies on diversified sourcing and compliance verification.

FAQs

Q1: Are there exclusive suppliers for ACTICLATE CAP?
A1: No. The market has multiple suppliers, especially after patent expiry, reducing dependency on any single source.

Q2: What are the primary countries producing the API?
A2: India and Israel lead API production for clindamycin.

Q3: How do regulatory requirements impact supplier selection?
A3: Suppliers must demonstrate GMP compliance, provide stability data, and meet regional regulatory standards.

Q4: What factors influence pricing for ACTICLATE CAP?
A4: Patent status, manufacturing scale, raw material costs, and regulatory compliance influence pricing.

Q5: Are there risks associated with sourcing from emerging markets?
A5: Yes; geopolitical issues, quality assurance, and supply chain reliability are potential concerns.


[1] U.S. Food and Drug Administration (FDA). (2022). Clindamycin API GMP Inspection Reports. Retrieved from https://www.fda.gov

[2] European Medicines Agency (EMA). (2022). Pharmacovigilance and Regulatory Policies. Retrieved from https://www.ema.europa.eu

[3] Indian Pharmacopoeia Commission. (2022). API Quality Standards. Retrieved from https://ipc.gov.in

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