Suppliers and packagers for CARTIA XT

CARTIA XT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	CARTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074752	ANDA	Actavis Pharma, Inc.	62037-597-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-05)	1998-07-09
Actavis Labs Fl Inc	CARTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074752	ANDA	Actavis Pharma, Inc.	62037-597-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-90)	1998-07-09
Actavis Labs Fl Inc	CARTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074752	ANDA	Actavis Pharma, Inc.	62037-598-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-598-05)	1998-07-09
Actavis Labs Fl Inc	CARTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	074752	ANDA	Actavis Pharma, Inc.	62037-598-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-598-90)	1998-07-09

Suppliers for the Pharmaceutical Drug: CARTIA XT

Last updated: August 6, 2025

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Introduction

CARTIA XT, known generically as verapamil extended-release, is a calcium channel blocker primarily used to treat hypertension, angina pectoris, and certain arrhythmias. As a widely prescribed medication, its supply chain involves multiple suppliers across the manufacturing, formulation, and distribution phases. Ensuring consistent supply, regulatory compliance, and quality standards is vital, given the critical nature of cardiovascular therapies.

Manufacturers of CARTIA XT

1. Original Manufacturer and Licensing

CARTIA XT was originally developed and marketed by Alphapharm (a division of AbbVie and formerly part of Abbott). Its proprietary formulation relies on controlled-release technology, which necessitates sophisticated manufacturing processes. Multiple authorized generic manufacturers and contract manufacturing organizations (CMOs) now produce verapamil extended-release formulations, including CARTIA XT.

2. Contract Manufacturing and OEM Suppliers

The complexity of controlled-release pharmaceuticals has led many brand owners to outsource manufacturing to specialized CMOs. These firms often possess proprietary technology, extensive regulatory approval experience, and quality assurance systems. Notable CMOs with documented capabilities in cardiovascular drug manufacturing include:

• Recipharm: A leader in controlled-release formulations, providing manufacturing services for various extended-release cardiovascular drugs.
• Hetero Labs: An Indian CMO with extensive experience in generic cardiovascular medications.
• Mylan (now part of Viatris): Has historically produced generic versions of verapamil formulations, potentially including CARTIA XT under license or via partnerships.

3. Generic Market Suppliers

As patent exclusivity has waned, several generic manufacturers have entered the market, supplying verapamil extended-release formulations. These include:

• Teva Pharmaceuticals
• Sandoz (Novartis)
• Mylan / Viatris
• Torrent Pharmaceuticals
• Cipla

Most of these companies produce formulations equivalent to CARTIA XT, though branding and formulation specifics can vary.

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Regulatory and Quality Considerations

1. Regulatory Approvals

Suppliers must obtain regulatory approvals from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and counterpart agencies in Asia, Latin America, and Africa. These approvals demand rigorous validation of manufacturing processes, stability, bioequivalence, and quality control measures.

2. Good Manufacturing Practice (GMP) Compliance

Manufacturers and CMOs supplying CARTIA XT or its generics must adhere to GMP standards. This ensures consistent drug potency, safety, and effectiveness across batches. Any deviation can disrupt supply chains and prompt regulatory action.

3. Supply Chain Transparency

An increasing trend emphasizes transparency and traceability in supplying critical medicines. Regulatory agencies and large healthcare providers often prefer suppliers with verifiable compliance, robust quality management systems, and contingency plans.

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Global and Regional Suppliers

North America

The U.S. market predominantly relies on authorized generics from companies like Mylan/Viatris, Teva, and Sandoz, alongside imported formulations approved via the FDA’s Abbreviated New Drug Application (ANDA) pathway.

Europe

European markets see a combination of original manufacturers' products and multiple approved generics. Local pharmaceutical companies and CMOs supplying the European Union (EU) adhere to EMA regulations.

Asia and Emerging Markets

India and China are significant sources for both generic and contract manufacturing supplies. Indian firms like Hetero Labs, Cipla, and Torrent Pharmaceuticals are prominent players, often supplying export markets under local regulatory approvals or international registrations.

Latin America and Africa

Suppliers often include regional manufacturers and imported generics that meet local regulatory standards. The emphasis is on affordable, reliable supply, sometimes via government procurement initiatives.

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Key Considerations for Procurement and Supply Chain Management

1. Certification and Compliance

Prospective buyers and distributors should verify supplier certifications, including GMP, ISO 9001, and regional drug authorities' approvals (e.g., FDA, EMA, CDSCO).

2. Product Authenticity and Intellectual Property

Ensuring product authenticity is crucial, especially given the prevalence of counterfeit medicines in cardiovascular drugs. Buyers should confirm supply chain transparency and authorized distribution channels.

3. Supply Security and Contingency Planning

To mitigate shortages, companies should diversify their supplier base across regions and manufacturers. Establishing contracts with multiple qualified suppliers ensures continuity.

4. Price and Market Dynamics

Prices vary widely based on formulation complexity, manufacturing scale, and regulatory exclusivity. In some markets, local manufacturing and reverse-engineered generics reduce costs, increasing access but raising concerns about quality and patent issues.

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Challenges in the Supply of CARTIA XT

1. Patent Landscape and Patent Expirations

Patent protections influence market entry and supplier diversity. As patents expire or face challenges, generic manufacturers gain market access, increasing supply options.

2. Quality Control and Manufacturing Capacity

Maintaining high manufacturing standards is imperative, especially for controlled-release formulations where variability can impact efficacy and safety.

3. Regulatory Delays and Compliance

New suppliers must navigate complex regulatory pathways, which may delay market entry or restrict distribution to authorized regions.

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Conclusion

The supply chain for CARTIA XT involves a combination of original developers, licensed generic manufacturers, and contract manufacturing organizations globally. The landscape is characterized by high regulatory standards, a proliferation of generics post-patent expiry, and significant regional variation. Ensuring consistent access involves vigilant supplier vetting, reactive contingency planning, and adherence to regulatory compliance.

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Key Takeaways

• Multiple global suppliers produce CARTIA XT or its equivalents, including original and generic manufacturers.
• Regulatory compliance, especially GMP adherence, remains paramount in supplier selection.
• Regional differences shape the supplier landscape, with India, Europe, and North America being key production hubs.
• Contract manufacturing organizations play a critical role in maintaining supply continuity amid complex formulation requirements.
• Proactive sourcing strategies and supply chain diversification are essential to mitigate shortages and ensure patient access.

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FAQs

1. Who are the primary manufacturers of CARTIA XT globally?
The original marketed version was by Alphapharm (AbbVie). Current supply includes authorized generics and generics produced by companies like Mylan/Viatris, Teva, Sandoz, Cipla, and Torrent Pharmaceuticals, often through licensing or contractual partnerships.

2. Are there regional differences in CARTIA XT suppliers?
Yes. North American markets largely depend on FDA-approved generics from companies like Mylan and Teva, while Indian and Asian markets may source from local CMOs like Hetero Labs and Cipla, with regional regulatory certifications.

3. What challenges do suppliers face in manufacturing CARTIA XT?
Key challenges include maintaining controlled-release formulation integrity, meeting stringent GMP standards, navigating regulatory approvals, and ensuring supply chain transparency.

4. How does patent status affect the availability of CARTIA XT?
Patent expirations have facilitated increased generic manufacturing, broadening the supplier base and reducing costs. However, patent litigation or extensions can temporarily restrict market entry.

5. What should healthcare providers consider when sourcing CARTIA XT?
Providers should verify supplier certifications, ensure product authenticity, comply with regional regulatory approvals, and establish contingency sourcing strategies to prevent shortages.

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Sources

1. [FDA Drug Approvals and Manufacturer Data]
2. [EMA Product Registration Database]
3. [Indian Central Drugs Standard Control Organization (CDSCO) Publications]
4. [Pharmacovigilance and GMP guidelines by WHO]
5. [Market reports on cardiovascular pharmaceuticals]