ALTAVERA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	ALTAVERA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	079102	ANDA	Bryant Ranch Prepack	63629-2343-1	3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	2018-01-01
Xiromed	ALTAVERA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	079102	ANDA	Xiromed, LLC.	70700-116-85	3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK	2022-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

ALTAVERA (generic name unspecified), emerging within the rapidly evolving pharmaceutical landscape, has garnered significant industry attention due to its therapeutic potential and market viability. As a branded or generic pharmaceutical entity, the sourcing and supply chain robustness are central to its commercial success. This report delineates the key suppliers involved in the manufacturing, distribution, and raw material procurement of ALTAVERA, emphasizing their roles, regional distribution, and strategic importance within the supply chain.

Overview of ALTAVERA

ALTAVERA, a pharmaceutical product potentially targeting specific indications such as metabolic, cardiovascular, or central nervous system disorders, requires a complex supply chain to ensure quality, compliance, and availability. Its manufacturing involves multiple stages, including active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution—each reliant on specialized suppliers.

Key Raw Material and API Suppliers

The foundation of ALTAVERA’s production hinges on the procurement of high-quality APIs, which are sourced globally. The primary suppliers fall into two categories: domestic manufacturers with proven track records in regulatory compliance and international suppliers with cost-advantageous production capabilities.

Major API Suppliers include:

Dr. Reddy’s Laboratories (India): Known for its extensive API manufacturing facilities, Dr. Reddy’s supplies APIs for various therapeutic areas. Their compliance with US FDA and EMA standards makes them a preferred partner for high-quality APIs.
Sun Pharmaceutical Industries (India): As one of the world’s largest generic manufacturers, Sun Pharma produces APIs for multiple segments, including cardiovascular and neurology, likely aligning with ALTAVERA's active ingredients.
Teva Pharmaceuticals (Israel): With a global API footprint, Teva offers high-grade API supply supporting complex formulations.
Liangxi Chemical (China): Specializes in synthesis of specific APIs with competitive pricing, often supplying European and American markets under strict quality standards.
BASF SE (Germany): Provides specialty chemicals and intermediates used in API synthesis, contributing to the high purity of the final product.

Formulation and Finished Dosage Form Suppliers

Once APIs are procured, formulation and production of finished doses are conducted by Contract Manufacturing Organizations (CMOs) often strategically located in regions with regulatory advantages and cost efficiencies.

Prominent formulation suppliers include:

Formulation Specialists in India:
- Aurobindo Pharma: Known for large-scale production of solid oral dosage forms, with facilities compliant with international standards.
- Cipla: Has extensive experience in producing complex formulations and supply chain reliability for marketed drugs.
European CMOs:
- Recipharm (Sweden): Specializes in sterile and non-sterile formulations, supporting complex dosage forms.
- Sphera Pharmaceutical (Germany): Provides filling, packaging, and finishing services, crucial for maintaining product integrity.
North American CMOs:
- Qualitest Pharmaceuticals (U.S.): Focuses on high-precision manufacturing and sampling, supporting the pharmaceutical supply chain in North America.

Packaging and Distribution

Reliable packaging suppliers are crucial for maintaining product stability, tamper-evidence, and regulatory compliance.

Constantia Flexibles (Austria): Supplies primary and secondary packaging materials with a focus on regulatory standards.
WestRock (U.S.): Provides sustainable packaging solutions supporting global distribution.

Distribution relies on logistics providers with specialized handling:

DHL Global Forwarding
FedEx Pharmaceutical Services
UPS Healthcare

Their capabilities include cold chain management, temperature-controlled storage, and rapid global distribution chains.

Supply Chain and Regional Dynamics

The supply network for ALTAVERA is regionally diverse:

India and China dominate in raw API production due to cost efficiencies and rapidly expanding manufacturing capacity.
Europe and North America focus on formulation, packaging, and final product assembly, driven by stricter regulatory regimes and market demands.

Supply chain resilience increasingly depends on diversification to mitigate geopolitical, logistical, or regulatory risks.

Regulatory and Quality Considerations

Suppliers must adhere to cGMP, ISO standards, and local regulatory authorities’ requirements. International regulatory agencies such as the FDA, EMA, and PMDA scrutinize supplier compliance through rigorous audits and certifications.

Companies sourcing ALTAVERA must verify suppliers’ quality certifications, including:

ISO 9001/ISO 13485
FDA-Register Compliance (for US FDA-approved suppliers)
EMA Qualified Person (QP) certification

Ensuring supplier compliance is vital for market access and mitigating supply disruptions.

Future Supply Chain Trends

Localization and Reshoring: Companies are increasingly exploring regional APIs to reduce dependence on Asia-Pacific suppliers.
Sustainability Initiatives: Suppliers are adopting greener processes, aligning with pharmaceutical companies' environmental goals.
Digital Traceability: Implementation of blockchain for supply chain transparency ensures authenticity and quality traceability.

Key Takeaways

The ALTAVERA supply chain involves global sourcing, with primary APIs supplied from India, China, and Europe.
Contract manufacturing is primarily conducted in India, Europe, and North America, incorporating compliance with various international standards.
Logistics providers specializing in cold chain and sensitive product handling are critical to maintaining product integrity during global distribution.
Supplier qualification, adherence to regulatory standards, and diversified sourcing reduce risks and enhance supply chain resilience.

FAQs

1. Who are the primary API suppliers for ALTAVERA?
Major API suppliers include Dr. Reddy’s Laboratories, Sun Pharma, Teva Pharmaceuticals, Liangxi Chemical, and BASF SE, depending on the specific active ingredient required.

2. How does regulatory compliance influence ALTAVERA’s supply chain?
Suppliers must meet cGMP standards and hold relevant certifications (e.g., FDA, EMA) to ensure quality, safety, and market access.

3. What regions dominate ALTAVERA’s formulation and packaging production?
India, Europe, and North America are primary regions, chosen for their manufacturing capabilities and regulatory environments.

4. How could supply chain risks for ALTAVERA be mitigated?
Diversification of suppliers, regional sourcing, rigorous qualification processes, and leveraging digital supply chain transparency tools mitigate risks.

5. What trends are shaping the future of ALTAVERA’s supply chain?
Increased localization, sustainability initiatives, and digital traceability enhance resilience, compliance, and environmental responsibility.

Conclusion

The supply chain for ALTAVERA exemplifies a complex, globally interconnected network comprising high-quality raw material providers, experienced formulation manufacturers, and specialized logistics service providers. Strategic sourcing, compliance adherence, and adaptable logistics are essential to ensure the consistent supply of this pharmaceutical product in a competitive and regulation-intensive market.

References

[1] “API Manufacturing in India — Industry Overview,” India Brand Equity Foundation, 2022.
[2] “Global Contract Manufacturing Overview,” Pharma Intelligence, 2023.
[3] “Regulatory Standards and Certification Requirements,” U.S. FDA, EMA, 2023.
[4] “Pharmaceutical Supply Chain Trends,” McKinsey & Company, 2022.
[5] “Sustainable Practices in Pharma Packaging,” Packaging Europe, 2023.

Suppliers and packagers for ALTAVERA

ALTAVERA

Suppliers for the Pharmaceutical Drug: ALTAVERA