qdolo: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Athena	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044	NDA AUTHORIZED GENERIC	TruPharma, LLC	52817-615-16	473 mL in 1 BOTTLE (52817-615-16)	2020-09-11
Athena	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044	NDA AUTHORIZED GENERIC	Palmetto Pharmaceuticals, Inc.	68134-402-40	4 TRAY in 1 CASE (68134-402-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68134-402-05)	2020-09-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape is dynamic and highly regulated, with a focus on sourcing by manufacturers and healthcare providers for a range of therapeutic agents. Among recently emerging drugs, Qdolo has gained notable attention as a potent analgesic developed for pain management. Ensuring a reliable supply chain for Qdolo requires understanding its key suppliers, manufacturing sources, and the regulatory landscape governing its distribution. This analysis explores the principal suppliers associated with Qdolo, the manufacturing facilities, and the strategic importance of these sources within the global pharmaceutical supply chain.

Overview of Qdolo

Qdolo, marketed as an innovative analgesic, combines novel pharmacological features aimed at providing effective pain relief with minimized dependency risks. Its active pharmaceutical ingredient (API) synthesis, formulation, and distribution are tightly controlled by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Given its relatively recent market introduction, supply chain considerations are critical for ensuring clinical availability and market expansion.

Manufacturers and Core Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

The primary determinant of Qdolo's supply security rests upon its raw material sources—especially the API manufacturing entities. Major API suppliers typically operate within regions such as India, China, and Europe, reflecting the globalized nature of pharmaceutical production.

Indian API Manufacturers: India remains a dominant supplier of pharmaceutical APIs, leveraging cost efficiencies and extensive manufacturing expertise. Companies like Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, and Cipla are among key players that could possess the capacity to produce APIs similar or related to Qdolo's compound. It is plausible that these firms either manufacture the API directly or supply intermediates.
Chinese API Producers: Companies such as Heng Tong Pharmaceutical and Shandong Hongxin Pharmaceutical Co., with extensive chemical synthesis backgrounds, are potential sources for APIs or intermediates used in Qdolo’s production.
European API Suppliers: Tier 1 European API manufacturers, including IPS Pharma and Fresenius Kabi, focus on high-quality, high-cost API production, often fulfilling supply needs where regulatory compliance standards are stringent.

Regulatory Compliance and Quality Standards

Critical to API sourcing is adherence to Good Manufacturing Practice (GMP) standards mandated by authorities such as the FDA and EMA. Manufacturers with WHO-GMP or equivalent certifications are preferred in managing the supply chain for Qdolo.

2. Formulation and Final Product Manufacturers

Once the API is obtained, formulation and packaging are conducted by specialized pharmaceutical contract manufacturing organizations (CMOs). These include:

Contract Manufacturing Organizations (CMOs): Globally recognized entities like Lonza, Catalent, and Thermo Fisher Scientific are candidates for final formulation, given their extensive capacity and regulatory compliance.
Domestic (U.S.) and European CMOs: Regulatory authorities favor local or regional CMOs for product assembly, ensuring faster approval cycles and quality assurance.

Supply Chain Dynamics

Global Supply Chain Complexity

The production of Qdolo exemplifies typical complexities in pharmaceutical manufacturing:

Dependency on API imports: A significant proportion of APIs are sourced from India and China, posing geopolitical and logistical risks, especially during supply chain disruptions such as COVID-19 or international trade tensions.
Regulatory hurdles: Compliance with stringent regulations affects supplier selection; only those with verified GMP certifications and robust quality controls operate within approved supply chains.
Distribution channels: After manufacturing, Qdolo is distributed through wholesalers, specialty pharmacies, and directly to healthcare institutions, depending on regional regulatory frameworks.

Strategic Supplier Relationships

Pharmaceutical companies investing in Qdolo’s supply chain prioritize establishing and maintaining strategic partnerships with key API suppliers. This ensures:

Continuity of supply
Competitive pricing
Quality assurance
Flexibility for scale-up during market expansion

Regulatory and Licensing Considerations

Manufacturers and suppliers of Qdolo must navigate a complex regulatory environment, including:

FDA and EMA approval: Any supplier involved in API or formulation must meet rigorous standards before being authorized in respective markets.
Import/export licenses: International movement of APIs and finished products requires adherence to customs and regulatory documentation.
Patent and exclusivity protections: Licensing agreements often restrict sourcing to approved manufacturers, making transparency and compliance critical.

Emerging Trends in Supplier Sourcing for Qdolo

Localization of Supply Chains: To mitigate geopolitical risks, pharmaceutical firms are increasingly investing in regional API production facilities. Such measures could influence future supplier choices for Qdolo.
Vertical Integration: Some pharmaceutical companies are pursuing vertical integration, manufacturing APIs and finished products in-house to reduce reliance on external suppliers.
Supply Chain Digitalization: Implementation of blockchain and advanced analytics enhances transparency and traceability in sourcing, accounting for quality and compliance assurance.

Conclusion

Ensuring a robust and compliant supply chain for Qdolo necessitates sourcing from reputed API producers and GMP-certified CMOs, primarily situated in India, China, and Europe. Strategic partnerships with these suppliers bolster supply security and product quality. As the drug advances through regulatory pathways and expands into new markets, supply chain resilience and transparency will remain top priorities.

Key Takeaways

Major API sources for Qdolo are predominantly located in India, China, and Europe, selected based on quality, cost, and regulatory compliance.
Regulatory adherence is paramount; suppliers must meet GMP standards mandated by authorities such as the FDA and EMA.
Supply chain risks, including geopolitical tensions and logistical disruptions, influence sourcing strategies—prompting a shift towards regional manufacturing and vertical integration.
Strategic partnerships with CMO and API manufacturers underpin market stability for Qdolo distribution.
Emerging technologies such as digital supply chain management enhance transparency and risk mitigation efforts.

FAQs

1. Who are the leading API suppliers for Qdolo?
API suppliers for Qdolo are likely major Indian companies such as Sun Pharmaceutical, Dr. Reddy's Laboratories, and Cipla, as well as Chinese firms like Heng Tong Pharmaceutical, all adhering to GMP standards.

2. Are there regional preferences for manufacturing Qdolo?
Yes. Due to regulatory, quality, and logistical considerations, manufacturing tends to favor regions with established GMP-certified facilities—namely India, China, and Europe.

3. How do regulatory standards impact supplier selection?
Suppliers must comply with GMP certifications recognized by agencies like the FDA and EMA. This compliance ensures product quality and facilitates regulatory approval processes.

4. What are the risks associated with relying on international API suppliers?
Risks include geopolitical instability, trade restrictions, supply chain disruptions (e.g., COVID-19), and quality control issues, which can impact steady supply.

5. What future trends could shape Qdolo’s supply chain?
Trends include localization of API manufacturing, increased adoption of digital supply chain tracking, and vertical integration by pharmaceutical companies to mitigate external dependencies.

References

[1] U.S. Food and Drug Administration. “Good Manufacturing Practice (GMP) Regulations.”
[2] European Medicines Agency. “Guidelines on the quality of medicines for human use.”
[3] Global Data. “Pharmaceuticals API Market Overview.”
[4] IQVIA. “Supply Chain Strategies in Pharmaceutical Manufacturing.”
[5] Deloitte. “Pharmaceutical Supply Chain Trends and Risks.”

Suppliers and packagers for qdolo

qdolo

Suppliers for the Pharmaceutical Drug: Qdolo