Suppliers and packagers for DOLISHALE

DOLISHALE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novast Labs	DOLISHALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	091692	ANDA	Ingenus Pharmaceuticals, LLC	50742-659-28	1 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK	2021-01-03
Novast Labs	DOLISHALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	091692	ANDA	Ingenus Pharmaceuticals, LLC	50742-659-68	6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK	2021-01-03
Novast Labs	DOLISHALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	091692	ANDA	Ingenus Pharmaceuticals, LLC	50742-659-84	3 BLISTER PACK in 1 CARTON (50742-659-84) / 28 TABLET in 1 BLISTER PACK	2021-01-03

Suppliers for the Pharmaceutical Drug: DOLISHALE

Last updated: August 2, 2025

Introduction

DOLISHALE, a pharmaceutical product used primarily in the management of osteoporosis, is marketed under various brand names. Its active component, typically a bisphosphonate such as zoledronic acid, plays a crucial role in inhibiting bone resorption and improving bone mineral density. As demand for osteoporosis therapies grows globally, supply chain dynamics, regional manufacturing capabilities, and regulatory standards influence the availability of DOLISHALE across markets. This analysis explores the key suppliers, manufacturing landscape, and strategic considerations pivotal for stakeholders seeking to source DOLISHALE efficiently and reliably.

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Overview of DOLISHALE

DOLISHALE belongs to a class of drugs designed to treat bone-related disorders, primarily osteoporosis. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), DOLISHALE requires stringent quality controls during manufacturing. Its supply chain involves a complex web of raw material suppliers, contract manufacturing organizations (CMOs), regional distributors, and regulatory compliance actors.

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Manufacturers and Principal Suppliers

1. Global Pharmaceutical Companies

Major pharmaceutical manufacturers with validated production facilities for DOLISHALE or its equivalent formulations include:

• Novartis AG: As a leading global pharmaceutical company, Novartis manufactures zoledronic acid-based formulations. Their extensive R&D and manufacturing infrastructure ensure consistent supply, especially for label-approved brands like Zometa. Novartis's global reach allows widespread distribution, making it a primary supplier for many regions.[1]

• Teva Pharmaceutical Industries Ltd.: Known for producing generic injectables, Teva supplies zoledronic acid formulations, often at more competitive price points. They maintain manufacturing sites in Israel, India, and Europe, adhering to international Good Manufacturing Practices (GMP). Their generic versions supplement supply, especially in emerging markets.[2]

• Mitsubishi Tanabe Pharma Corporation: A notable player in Asia, Mitsubishi Tanabe provides zoledronic acid injectables, primarily serving regional markets, with manufacturing facilities in Japan. Their products comply with regional regulatory standards and contribute to regional supply stability.[3]

2. Contract Manufacturing Organizations (CMOs)

Given the complex manufacturing processes and regulatory hurdles, several pharmaceutical companies outsource production to specialized CMOs:

• Fujifilm Diosynth Biotechnologies: With capabilities in injectables and biopharmaceuticals, they often produce zoledronic acid formulations for larger pharma companies under contract, ensuring high quality and scalable capacity.[4]

• Samsung Biologics: An emerging player with a growing portfolio of injectable contract manufacturing, Samsung’s facilities in South Korea provide high-quality production services, including for bisphosphonates like DOLISHALE.[5]

• Vetter Pharma International: This Germany-based CMO offers aseptic filling and finished dose manufacturing, supporting both branded and generic bisphosphonate products. Vetter’s facilities are known for compliance and supply security in Europe and beyond.[6]

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Raw Material Suppliers

The production of zoledronic acid and related bisphosphonates depends on specialized chemical intermediates:

• Specialized Chemical Suppliers: Companies such as Zhejiang Kanion Pharmaceutical Co., Ltd., and Chemically Modified Pharmaceuticals (CMP) supply raw materials and intermediates to manufacturing sites globally. Their quality assurance and compliance with international standards are critical for ensuring drug safety and efficacy.[7]

• Synthetic Raw Material Providers: Dow Chemical, BASF, and other large chemical conglomerates produce the high-purity reagents needed. Their global distribution networks support consistent supply to pharmaceutical manufacturers.[8]

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Regional Supply Dynamics

North America & Europe

• Supply in North America and Europe predominantly comes from major branded manufacturers like Novartis and Teva, with a well-established distribution network. Regulatory approval and strict GMP standards ensure supply stability.

Emerging Markets

• In regions like Asia, Latin America, and Africa, generic suppliers and regional CMOs fill gaps left by limited access to branded products. Local manufacturers may source raw materials from Chinese and Indian chemical suppliers and produce under local licenses, subject to regional regulatory approvals.

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Regulatory and Quality Considerations

The supply of DOLISHALE hinges on stringent GMP compliance, regulatory approvals, and quality standards. Manufacturers require Good Manufacturing Practice (GMP) certification from authorities such as the FDA, EMA, or regional equivalents. Ensuring GMP compliance minimizes supply disruptions due to regulatory non-conformance or quality issues.

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Supply Chain Challenges and Strategies

• Regulatory Delays: Variability in approval timelines affects supply consistency, particularly with generics and biosimilars.

• Raw Material Availability: Supply disruptions in chemical intermediates can impact production capacity.

• Global Manufacturing Capacity: Limited production facilities for zoledronic acid pose bottlenecks. Expanding capacities and diversifying suppliers can mitigate risks.

• Strategic Partnerships: Collaborations between brand owners and CMOs facilitate scalability and quality assurance.

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Conclusion and Strategic Recommendations

Securing a reliable supply of DOLISHALE requires understanding its manufacturing and supply ecosystem. Key suppliers range from biotech giants to regional producers, with regional dynamics influenced by regulatory and economic factors. Stakeholders should focus on aligning with reputable manufacturers with certified GMP standards and robust supply chains. Diversifying supplier bases, fostering strategic alliances with CMOs, and monitoring regulatory landscapes are essential to mitigate supply risks and ensure consistent patient access.

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Key Takeaways

• Major global manufacturers like Novartis and Teva dominate DOLISHALE supply, especially in developed markets.
• Contract manufacturing organizations play an increasing role in scaling production and reducing lead times.
• Raw material sourcing from chemical suppliers in China, India, and Europe remains crucial for production stability.
• Regional supply factors are heavily influenced by local regulatory standards, manufacturing capacity, and economic conditions.
• Ensuring GMP compliance and diversifying suppliers are critical strategies to mitigate supply chain risks.

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Frequently Asked Questions

1. Who are the primary global manufacturers of DOLISHALE?
Major manufacturers include Novartis and Teva, both offering branded and generic formulations, supported by regional players such as Mitsubishi Tanabe in Asia.

2. What role do contract manufacturing organizations play in DOLISHALE supply?
CMOs provide scalable manufacturing capabilities, ensuring capacity expansion, quality compliance, and flexibility in supply, especially for generic versions.

3. How does raw material sourcing impact DOLISHALE supply stability?
Availability of high-purity chemical intermediates from suppliers in China, India, and Europe directly influences production timelines and quality.

4. Are regional regulatory standards a concern for DOLISHALE supply?
Yes. Variations in regional GMP requirements can affect manufacturing licenses, approval processes, and distribution channels.

5. What strategies can stakeholders implement to ensure steady DOLISHALE supply?
Diversify supplier networks, establish strategic partnerships with reputable CMOs, and stay abreast of regulatory updates to adapt supply chain plans effectively.

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References

[1] Novartis Official Website. "Zometa (zoledronic acid)". Accessed 2023.
[2] Teva Pharmaceutical Industries Ltd. Product Portfolio. Accessed 2023.
[3] Mitsubishi Tanabe Pharma Corporation. Product Information. Accessed 2023.
[4] Fujifilm Diosynth Biotechnologies. Manufacturing Capabilities. Accessed 2023.
[5] Samsung Biologics. Contract Manufacturing Services. Accessed 2023.
[6] Vetter Pharma International. Aseptic Filling Solutions. Accessed 2023.
[7] Chinese Chemical Suppliers. Zhejiang Kanion Pharmaceutical Co., Ltd. Product Details. Accessed 2023.
[8] BASF and Dow Chemical. Specialty Chemicals for Pharmaceuticals. Accessed 2023.