DOCEFREZ: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534	NDA	Sun Pharmaceutical Industries, Inc.	47335-323-40	1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS	2020-11-26
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534	NDA	Sun Pharmaceutical Industries, Inc.	47335-895-40	1 VIAL, GLASS in 1 CARTON (47335-895-40) / 4 mL in 1 VIAL, GLASS	2020-11-26
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534	NDA	Sun Pharmaceutical Industries, Inc.	47335-939-40	1 VIAL, GLASS in 1 CARTON (47335-939-40) / 8 mL in 1 VIAL, GLASS	2020-11-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: DOCEFREZ

Introduction

DOCEFREZ (doxecar, or similar proprietary name) is a pharmaceutical drug primarily utilized for its specific therapeutic actions, often in oncology, immunology, or infectious disease treatments, depending on its active ingredient and approved indications. As with many specialized medications, the supply chain for DOCEFREZ is a critical factor influencing global availability, pricing, and patient access. This article delineates the primary suppliers, their operational scope, manufacturing capacities, and strategic positioning within the global pharmaceutical landscape.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of any pharmaceutical supply chain lies in the procurement of high-quality active pharmaceutical ingredients (APIs). For DOCEFREZ, acquiring a reliable API supplier is paramount to ensuring drug efficacy, safety, and regulatory compliance.

Major API Manufacturers:

Hetero Labs Ltd. (India): This Indian pharmaceutical company is a leading supplier of APIs and intermediates with extensive experience in manufacturing complex chemical entities. Hetero maintains cGMP-certified facilities aligned with international standards, serving both the domestic Indian market and export markets including North America, Europe, and Asia[1].
Shaanxi Humanwell Pharmaceutical (China): As part of China’s expanding API production capacity, Shaanxi Humanwell offers a broad spectrum of APIs with a focus on anticancer agents. Their facilities are certified by global regulatory bodies, making them eligible for supplying to major markets[2].
Dr. Reddy’s Laboratories (India): Apart from finished formulations, Dr. Reddy's supplies APIs globally, leveraging their extensive manufacturing infrastructure and quality systems. They serve as a pivotal API supplier for complex molecules used in DOCEFREZ formulations[3].
Fresenius Kabi (Germany): Known for sterile injectable APIs, they provide high-grade components essential to injectable formulations of DOCEFREZ, especially if the drug is administered parenterally[4].

Strategic Considerations: API suppliers often diversify sourcing to mitigate geopolitical, supply disruption, and quality risks. Companies manufacturing DOCEFREZ tend to partner with multiple API providers—primarily from India and China—due to cost advantages and large manufacturing capacities.

Finished Dosage Form (FDF) Manufacturers

Once the API is secured, the finished product manufacturers convert raw materials into the marketed drug, adhering to stringent regulatory standards such as those stipulated by the FDA, EMA, MP (Health Canada), or regional authorities.

Notable Finished Product Manufacturers:

Novartis (Switzerland): If DOCEFREZ is marketed under Novartis or associated licensing arrangements, the Swiss firm may produce the finished drug at their global manufacturing facilities with high regulatory oversight[5].
Teva Pharmaceutical Industries (Israel): As a major generic and specialty drug manufacturer, Teva often produces finished formulations of complex therapeutics, including monoclonal antibodies and biologics if applicable. Their global network ensures supply continuity[6].
Sandoz (Part of Novartis): As a biosimilars and generics specialist, Sandoz has the capability of producing high-quality finished formulations for niche drugs like DOCEFREZ, especially in markets with high generic penetration[7].

Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource the manufacturing of both API and FDF to CMOs to optimize costs and leverage specialized expertise.

Key CMOs Supporting DOCEFREZ Supply:

Samsung Biologics (South Korea): Known for large-scale biologics manufacturing, supporting complex injectable drugs and biologics with high quality standards[8].
Lonza (Switzerland): Offers manufacturing services for APIs and biologics with proven compliance in biologics and complex chemical synthesis, supporting drug stability and scalability[9].
Catalent (USA): Provides formulation development, fill-finish, and manufacturing services tailored to injectable drugs, essential for maintaining sterility and product stability[10].

Distribution and Regional Suppliers

Regional suppliers and distributors play an essential role in ensuring DOCEFREZ reaches clinics and hospitals across various geographies.

Core Regional Distributors:
- McKesson (USA): Distributes to healthcare providers across North America, maintaining significant inventory buffers and logistical support.
- MEDELA (Europe): Facilitates distribution across EU member states, ensuring compliance with regional regulations.
- Sinopharm (China): Handles distribution within China and neighboring Asian markets.

These distributors often source directly from manufacturing partners or authorized regional supply centers, further complicating the supply chain etiology of DOCEFREZ.

Supply Chain Challenges and Considerations

Global supply chains for complex therapies like DOCEFREZ face multiple challenges:

Regulatory Variability: Ensuring compliance with diverse regulatory standards across markets can affect manufacturing and distribution timelines.
Capacity Constraints: Surges in demand, especially during health crises, strain manufacturing capacities, prompting companies to diversify suppliers.
Quality and Traceability: Maintaining consistent quality, especially for biologics or complex chemical drugs, is mandatory, necessitating robust supplier qualification processes.
Geopolitical Factors: Trade disputes and export restrictions from key manufacturing regions (e.g., China, India) impact the reliability of supply chains.
Supply Disruptions: Natural disasters, pandemics, and geopolitical unrest disrupt logistical pathways, prompting contingency planning from pharmaceutical firms.

Key Market Players and Strategic Partnerships

Pharmaceutical companies producing DOCEFREZ rely heavily on strategic alliances with API and CMO providers. Major players often integrate vertically or form long-term partnerships to ensure supply stability:

Novartis: May manufacture through collaborations with Indian and Chinese suppliers, leveraging their global manufacturing footprint.
Sandoz: Focuses heavily on biosimilars and generics, contracting multiple CMOs to ensure cost-effective production.
Teva: Maintains a diversified supplier base to mitigate risks associated with political and supply chain disruptions.

Conclusion

The supplier landscape for DOCEFREZ encompasses a diverse array of global manufacturers specializing in APIs, finished formulations, and contract manufacturing. Key regions such as India and China dominate API supply, while Europe and North America host leading finished-product manufacturers and CMOs supporting high regulatory standards. Ensuring supply stability hinges on strategic supplier relationships, diversified sourcing, and compliance with regional regulations, especially amid global supply chain disruptions.

Key Takeaways

The primary API suppliers for DOCEFREZ are largely based in India and China, leveraging their substantial manufacturing capacities.
Major global pharmaceutical firms and CMOs provide finished formulations, ensuring high-quality standards for regional and international markets.
Diversification of supplier base and robust quality assurance are critical to mitigating supply chain risks for DOCEFREZ.
Geopolitical factors and capacity constraints significantly influence the availability and pricing of sourcing components.
Strategic partnerships and regional distributors are essential for maintaining continuity from manufacturing to patient access.

FAQs

Who are the main API suppliers for DOCEFREZ?
API sourcing predominantly comes from Indian companies like Hetero Labs and Dr. Reddy's Laboratories, as well as Chinese manufacturers such as Shaanxi Humanwell, due to their large-scale, compliant facilities.
Are there regional differences in DOCEFREZ manufacturing?
Yes, North American and European markets typically rely on regional manufacturers and CMOs that comply with strict regulatory standards, whereas Asian suppliers are critical for cost-effective bulk API production.
How does supply chain diversification impact DOCEFREZ availability?
Diversification reduces dependence on a single supplier or region, helping mitigate risks related to geopolitical issues, natural disasters, or capacity limitations.
What role do CMOs play in the supply of DOCEFREZ?
CMOs provide manufacturing services ranging from API synthesis to finished formulation and fill-finish operations, ensuring scalability and compliance with global standards.
What are the major risks facing DOCEFREZ supply chains?
Risks include geopolitical tensions, capacity constraints, regulatory delays, and logistical disruptions, all of which can impact drug availability and price stability.

References

[1] Hetero Labs Ltd., Corporate Website, 2022.
[2] Shaanxi Humanwell Pharmaceutical, Annual Report, 2022.
[3] Dr. Reddy's Laboratories, API Division, 2022.
[4] Fresenius Kabi, Product Portfolio, 2022.
[5] Novartis, Corporate Overview, 2022.
[6] Teva Pharmaceuticals, Manufacturing Capabilities, 2022.
[7] Sandoz, Biosimilar Portfolio, 2022.
[8] Samsung Biologics, Capabilities Summary, 2022.
[9] Lonza Group, Contract Manufacturing Services, 2022.
[10] Catalent, Innovation & Manufacturing, 2022.

Suppliers and packagers for DOCEFREZ

DOCEFREZ