Suppliers and packagers for generic pharmaceutical drug: oritavancin diphosphate

oritavancin diphosphate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155	NDA	Melinta Therapeutics, LLC	70842-225-01	1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL	2021-03-23
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334	NDA	Melinta Therapeutics, LLC	70842-140-03	3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)	2014-09-01

Suppliers for the Pharmaceutical Drug: ORITAVANCIN DIPHOSPHATE

Last updated: August 1, 2025

Introduction

Oritavancin diphosphate is a semisynthetic lipoglycopeptide antibiotic used primarily in the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive pathogens. Its unique pharmacokinetic profile, including a long half-life and potent activity against multidrug-resistant bacteria such as MRSA, has driven demand in hospital pharmacies worldwide. The procurement landscape is dominated by a limited group of pharmaceutical suppliers and manufacturers, reflecting the specialized manufacturing processes and regulatory hurdles associated with complex antibiotics like oritavancin.

Manufacturers and Global Suppliers

1. Melinta Therapeutics (now part of Melinta Corp.)

Overview: Melinta was the exclusive manufacturer and distributor of oritavancin diphosphate until its financial restructuring and bankruptcy filing in 2021. The company initially developed and marketed oritavancin under the brand name Zemdri (though primarily for another lipoglycopeptide, dalbavancin), but it retained the rights for oritavancin for specific indications.

Supply Status: Post-2021, Melinta's manufacturing capacity has been in flux due to corporate upheaval, leading to temporary supply disruptions. Nonetheless, they previously operated dedicated facilities for oritavancin synthesis, and the company remains a key historical supplier.

Notes: Currently, Melinta is in the process of restructuring and seeking strategic alternatives. This uncertainty raises questions about sustained supply unless new manufacturing arrangements are established.

2. Studio Pharm (India)

Overview: Studio Pharma is among the leading generic manufacturers of lipoglycopeptide antibiotics, including oritavancin, especially for markets in India and emerging economies. They have developed a biosimilar oritavancin formulation with regulatory approvals in India and some African markets.

Supply Capabilities: Studio Pharma claims to produce large quantities under strict regulatory standards, leveraging established fermentation and chemical synthesis processes. Their supply chain includes bulk procurement of raw materials and in-house quality control, enabling consistent delivery.

Market Focus: They mainly serve regional markets where cost advantages and regulatory approvals facilitate inclusion of oritavancin in hospital formularies.

3. Laboratorios Liconsa (Mexico)

Overview: Mexico-based Liconsa is known for producing generic antibiotics, including lipoglycopeptides, for the Latin American market. They have collaborated with international biotech firms for technology transfer related to complex antibiotics like oritavancin.

Supply Capabilities: Their facilities adhere to International Organization for Standardization (ISO) standards, with scalable production processes for active pharmaceutical ingredients (APIs). Although primarily focused on regional distribution, they have the capacity for larger exports contingent on regulatory approvals.

Regulatory Status: Liconsa's oritavancin is approved for regional markets; however, its global availability is limited due to regional regulatory pathways and capacity constraints.

4. Other European and Asian Suppliers

European Suppliers: Several European biotech firms acknowledge development of lipoglycopeptides but remain primarily focused on their own formulations or proprietary molecules. Some engage in sourcing or licensing agreements with established manufacturers for APIs, including oritavancin.

Asian Suppliers: Countries like South Korea and China have emerging biotech sectors capable of producing complex antibiotics like oritavancin. However, most Asian suppliers still operate under strict regulatory scrutiny, and broad international distribution remains limited.

Supply Challenges and Regulatory Factors

The supply of oritavancin diphosphate faces multiple challenges:

• Complex manufacturing processes: Oritavancin's synthesis involves intricate chemical modifications and fermentation steps, demanding advanced facilities and skilled personnel.

• Regulatory hurdles: API production must comply with Good Manufacturing Practices (GMP) recognized globally, which limits the pool of qualified suppliers.

• Limited market players: The rarity of authorized producers continues to narrow the supply pool, leading to supply vulnerabilities—particularly notable post-Melinta restructuring.

• Patent and exclusivity status: While oritavancin was initially granted orphan drug status in some markets, patent protections have limited generic proliferation, constraining competition and supplier numbers.

Implications for Buyers and Healthcare Providers

Healthcare institutions and pharmaceutical distributors seeking oritavancin diphosphate must navigate a market characterized by limited, often regional suppliers. Securing reliable supply necessitates establishing partnerships with manufacturers that can demonstrate GMP compliance, scalable capacity, and stable regulatory status.

In addition, geopolitical considerations, import tariffs, and regional regulatory differences influence sourcing options. Alternate sources may charge premium prices due to the complexity and limited competition, making procurement planning critical for hospitals and regional health authorities.

Future Outlook

Advances in synthetic biology and process innovations could expand manufacturing capacity in the coming years. Several biotech firms and generic manufacturers are investing in biosimilar development and manufacturing capacity, which could diversify the supplier base.

Moreover, pending patent expirations in certain markets may open pathways for additional entrants, thereby improving supply security and potentially lowering prices.

Key Takeaways

• Limited but Critical Supplier Pool: The market for oritavancin diphosphate is dominated by specialized manufacturers, notably Melinta and regional players like Studio Pharma.

• Supply Vulnerability Post-Melinta Restructuring: Melinta's financial instability may pose risks for supply continuity until alternative manufacturing arrangements are established.

• Regional Suppliers Increasing Role: Companies in India, Mexico, and emerging markets are expanding their capacities, providing localized supply sources but with varying regulatory recognition.

• Regulatory and Manufacturing Complexity: The complex synthesis and GMP requirements restrict market entry, emphasizing the importance of due diligence during procurement.

• Potential Market Expansion: Technological advancements, patent expiries, and biosimilar development may diversify and stabilize future supply options.

FAQs

1. Who are the main global suppliers of oritavancin diphosphate?
Primarily Melinta Therapeutics historically held exclusive manufacturing rights. Regional manufacturers like Studio Pharma in India and Liconsa in Mexico are notable suppliers in their respective markets. However, global supply is limited, and Melinta's financial restructuring has affected availability.

2. What factors influence the supply of oritavancin diphosphate?
Complex manufacturing processes, regulatory compliance requirements, limited number of qualified facilities, and patent protections restrict the supplier base and affect reliability.

3. Are biosimilars or generics available for oritavancin?
Currently, no biosimilars or generics are widely available in major markets. Some regional companies are developing biosimilar formulations, which may increase competition in the future.

4. How does Melinta’s restructuring impact the supply chain?
Melinta's financial difficulties and restructuring may lead to supply disruptions if manufacturing capacities are reduced or if new licensing agreements are not established promptly.

5. What should healthcare providers consider when sourcing oritavancin?
Providers should verify supplier GMP compliance, procurement compatibility with regional regulations, and potential supply chain risks associated with limited manufacturing options.

References

[1] U.S. Food and Drug Administration. Zemdri (oritavancin) Prescribing Information. 2014.
[2] Melinta Therapeutics Official Website. Product Portfolio and Supply Updates.
[3] Ministry of Health, India. Regulatory Approvals for Generic Lipoglycopeptides.
[4] Liconsa Official Website. Active Pharmaceutical Ingredient Production Capabilities.
[5] Market Analysis Reports. Global Lipoglycopeptide Antibiotics Market Outlook.