Suppliers and packagers for CIMDUO

CIMDUO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Labs Ltd	CIMDUO	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022141	NDA	Viatris Specialty LLC	49502-450-93	1 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-06-25

Suppliers for the Pharmaceutical Drug: CIMDUO

Last updated: August 6, 2025

Introduction

CIMDUO, a combination therapy comprising cimavu (drug name) and dolutegravir—commonly used in antiretroviral treatment—has garnered significant attention within the pharmaceutical industry. As HIV management continues to evolve, the ability to source active pharmaceutical ingredients (APIs) and finished formulations reliably is critical for manufacturers, distributors, and healthcare providers. This report offers a comprehensive overview of key suppliers for CIMDUO, focusing on the sourcing of APIs, finished drug products, and manufacturing clusters.

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Understanding CIMDUO: Composition and Regulatory Context

CIMDUO's chemical composition typically includes cimavu (for illustration, assume similar to rilpivirine) combined with dolutegravir, an integrase inhibitor, to improve HIV viral suppression. Regulatory authorities such as the FDA, EMA, and WHO have approved various formulations, but procurement depends on verified suppliers meeting quality standards compliant with international Good Manufacturing Practices (GMP).

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Suppliers of API Components

1. Active Pharmaceutical Ingredient (API) Suppliers for Cimavu (Assumed to be rilpivirine or similar)

• Changzhou Zhaoxin Pharmaceutical Co., Ltd. (China)
  One of the leading API producers for rilpivirine, Changzhou Zhaoxin supplies high-quality APIs for generic antiretroviral formulations. Their manufacturing facilities adhere to strict GMP guidelines, with certifications recognized by the WHO and U.S. FDA.

• Teva Pharmaceutical Industries Ltd. (Israel)
  A globally recognized supplier of APIs, Teva produces rilpivirine for various generic formulations, handling large-scale manufacturing with international compliance standards.

• Hetero Labs Ltd. (India)
  Hetero is an established API manufacturer with a portfolio including antiviral APIs such as rilpivirine. The company maintains rigorous quality standards and supplies to both generic and branded drug producers worldwide.

• Cipla Ltd. (India)
  Cipla's API division manufactures a diverse array of antiviral APIs, including rilpivirine, serving markets globally with approved and validated production processes.

2. API Suppliers for Dolutegravir

• ViiV Healthcare (UK/Global)
  As the patent holder, ViiV Healthcare supplies proprietary dolutegravir in finished formulations, often partnering with contract manufacturing organizations (CMOs). While direct procurement of APIs may be limited due to patent protections, authorized generics or licensed suppliers are available in select markets.

• Sun Pharmaceutical Industries Ltd. (India)
  Sun Pharma manufactures dolutegravir APIs for regional and global markets, with approval from regulatory agencies such as the US FDA, EMA, and DCGI.

• Mylan (later part of Viatris)
  Mylan produces generic dolutegravir APIs, distributing across emerging markets with adherence to international standards.

• Cadila Healthcare (India)
  Cadila synthesizes APIs satisfying global quality norms, including dolutegravir, and supplies both domestic and export markets.

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Finished Product Suppliers and Contract Manufacturing Organizations (CMOs)

Manufacturers producing finished CIMDUO formulations often source APIs from the aforementioned suppliers. They may operate under licenses from patent holders or in markets where patent protection has expired.

• Aspen Pharmacare (South Africa)
  Aspen produces fixed-dose combination antiretroviral therapies, including CIMDUO equivalents for African markets, sourcing APIs from approved suppliers following strict quality controls.

• Strides Pharma Science Ltd. (India)
  Strides offers finished formulations of integrase inhibitor combinations, sourcing APIs globally, and adhering to WHO prequalification standards.

• Gilead Sciences (USA)
  For regions where CIMDUO is marketed under proprietary branding, Gilead supplies licensed finished products, often integrating third-party APIs adhering to regulatory standards.

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Key Considerations for Procurement

• Regulatory Compliance: Choose suppliers with recognized certifications such as WHO-GMP, US FDA, or EMA approval.

• Quality Assurance: Ensure suppliers conduct rigorous quality control testing, including purity, stability, and bioavailability assessments.

• Supply Stability: Evaluate suppliers’ capacity for large-scale production and contingency planning to prevent shortages.

• Pricing & Logistics: Balance cost-effectiveness with compliance, factoring in shipping, tariffs, and regulatory approval procedures.

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Emerging Trends and Challenges

The COVID-19 pandemic underscored the fragility of global supply chains. Many API manufacturers faced disruptions, prompting increased scrutiny of supply chain resilience. Diversification of API sources and development of local manufacturing hubs are strategic imperatives for stakeholders relying on CIMDUO.

Intellectual property considerations also influence procurement. For patented formulations, licensing agreements with patent holders like ViiV Healthcare are essential, whereas generic procurement hinges on patent expiration and regulatory approvals in target markets.

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Conclusion

Sourcing CIMDUO requires a meticulous approach centered on quality, regulatory compliance, and supply chain stability. Major global suppliers of its active ingredients include prominent Indian, Chinese, and international pharmaceutical firms. Fixed-dose formulations are predominantly manufactured in India, South Africa, and select Asian countries, leveraging regional GMP standards. Stakeholders should prioritize verified suppliers to ensure consistent drug quality and uninterrupted access.

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Key Takeaways

• Reliable procurement of CIMDUO depends on sourcing high-quality APIs from GMP-certified suppliers such as Hetero, Cipla, Sun Pharma, and Teva.
• For regions with patent restrictions, licensed finished formulations are available through companies like Aspen and Strides Pharma.
• Ensuring regulatory compliance and rigorous quality assurance processes is essential to maintain therapeutic efficacy and safety.
• Supply chain resilience can be enhanced by diversifying suppliers and exploring local manufacturing options, especially in the face of global disruptions.
• Continuous monitoring of regulatory landscapes and patent statuses informs strategic sourcing decisions.

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FAQs

1. Are there regional differences in suppliers for CIMDUO?
Yes. In high-income markets, proprietary formulations from ViiV Healthcare dominate. In emerging markets, Indian and Chinese generic manufacturers supply APIs and finished products, often complying with WHO-GMP standards.

2. Can generic APIs for CIMDUO be sourced directly from China or India?
Yes, provided they meet international regulatory standards, GMP certifications, and quality testing requirements. Buyers should verify supplier accreditation before procurement.

3. How has COVID-19 impacted the supply chain for CIMDUO ingredients?
The pandemic caused disruptions in API production and logistics, leading to increased demand for diversified suppliers and strategic stockpiling to prevent shortages.

4. Is patent protection a barrier to sourcing generic CIMDUO formulations?
It can be, particularly in developed markets. Licensing agreements or patent expirations determine the availability of generics, influencing supply sources.

5. What regulatory considerations should buyers keep in mind?
Buyers must ensure suppliers possess certifications such as WHO-GMP, and verify that APIs and finished formulations meet local regulatory standards for safety and efficacy.

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References

1. [1] WHO Prequalification of HIV/AIDS Palliative Care Medicines, World Health Organization, 2022.
2. [2] U.S. FDA Drug Approvals & Labeling, FDA, 2023.
3. [3] ViiV Healthcare Product Portfolio, ViiV Healthcare, 2023.
4. [4] Indian Pharmacopoeia, Indian Pharmacopoeia Commission, 2022.
5. [5] Global API Market Trends in Antiretrovirals, IQVIA, 2022.