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Suppliers and packagers for PROVOCHOLINE
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PROVOCHOLINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Methapharm | PROVOCHOLINE | methacholine chloride | FOR SOLUTION;INHALATION | 019193 | NDA | Methapharm Inc. | 64281-100-06 | 6 VIAL, GLASS in 1 BOX (64281-100-06) / 100 mg in 1 VIAL, GLASS (64281-100-00) | 2013-03-27 |
| Methapharm | PROVOCHOLINE | methacholine chloride | FOR SOLUTION;INHALATION | 019193 | NDA | Methapharm Inc. | 64281-110-06 | 6 PACKAGE in 1 PACKAGE (64281-110-06) / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00) | 2022-03-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PROVOCHOLINE
Introduction
Provocholine, the brand name for cholinergic agent used predominantly for diagnostic purposes, is an essential tool in clinical settings for evaluating autonomic nervous system function, namely in cardiac stress testing. Its active ingredient, acetylcholine chloride, triggers specific physiological responses, such as inducing bronchoconstriction or vasodilation, to aid diagnosis.
Given its narrow therapeutic window and essential role, reliable supply chains for Provocholine and its active component, acetylcholine chloride, are critical for healthcare providers and pharmaceutical distributors. This report provides a comprehensive overview of current suppliers of Provocholine and its constituent chemicals, examining manufacturing sources, market dynamics, and procurement considerations within the global pharmaceutical supply landscape.
1. Regulatory and Market Overview
Provocholine is primarily marketed for diagnostic purposes in the United States and certain European markets. Its regulatory status varies; it is approved and regulated by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As a diagnostic agent, it faces less scrutiny compared to therapeutic drugs but still requires stringent quality assurance.
The drug’s production hinges on high-grade acetylcholine chloride, which is classified as an active pharmaceutical ingredient (API). Suppliers must adhere to Good Manufacturing Practice (GMP) standards to ensure purity and safety.
Market demand for Provocholine is relatively niche; however, the specialized nature of its use sustains a limited number of dedicated suppliers, often with proprietary formulations. The global supply chain's robustness depends heavily on the availability of high-quality acetylcholine chloride and reliable manufacturing partnerships.
2. Key Suppliers of Acetylcholine Chloride
a. Major API Manufacturers
Several manufacturers produce acetylcholine chloride as an API, supplying to pharmaceutical companies producing Provocholine:
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Sigma-Aldrich (Merck Group)
As a leading global distributor of research chemicals and pharmaceutical APIs, Sigma-Aldrich offers acetylcholine chloride suitable for pharmaceutical formulations. Its products comply with stringent quality specifications, and it supplies to pharmaceutical manufacturers globally ([1]). -
Siegfried AG
A Swiss-based manufacturer specializing in custom synthesis and production of active pharmaceutical ingredients, including acetylcholine chloride. Siegfried emphasizes high purity and GMP compliance, serving pharmaceutical firms worldwide ([2]). -
Rotam Chemicals
A major supplier of specialty chemicals and APIs in Asia, Rotam offers acetylcholine chloride for pharmaceutical and research use, with a focus on quality assurance and supply chain reliability ([3]). -
Hanmi Chemical Co., Ltd.
A South Korean pharmaceutical ingredients manufacturer with capabilities in producing acetylcholine chloride at pharmaceutical standards, catering to Asia and beyond ([4]).
b. Specialty Chemical Contractors
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Bachem
Known for peptide synthesis and APIs, Bachem also supplies acetylcholine chloride, particularly for laboratory and diagnostic applications. Their manufacturing facilities meet GMP standards, ensuring consistent quality ([5]). -
Aartes
Provides custom synthesis services with GMP-certified production, including acetylcholine derivatives used in diagnostic agents.
c. Regional Suppliers and Distributors
Regional suppliers often act as intermediaries, sourcing APIs from primary manufacturers to provide localized procurement options, ensuring supply chain flexibility and cost competitiveness.
3. Production and Procurement Challenges
Limited Manufacturing Capacity:
As a niche API, acetylcholine chloride production is limited to specialized manufacturers. Capacity constraints and quality control issues can lead to supply shortages or delays.
Regulatory Compliance:
Suppliers must maintain GMP standards and obtain regulatory approvals, which can be a lengthy process, influencing supply stability.
Global Supply Chain Disruptions:
COVID-19 pandemic impacts, geopolitical tensions, and raw material shortages have underscored vulnerabilities affecting API availability, especially for specialty chemicals like acetylcholine chloride.
Price Volatility:
The specialized nature of acetylcholine chloride results in pricing sensitivity influenced by demand fluctuations and manufacturing costs.
4. Suppliers of Commercially Manufactured Provocholine
Beyond APIs, companies responsible for formulating, bottling, and distributing Provocholine include:
-
MediClinic (Daiichi Sankyo)
A distributor providing licensed Provocholine in select markets, sourcing APIs from trusted manufacturers ([6]). -
Luitpold Pharmaceuticals (now part of Esteve Pharmaceuticals)
Historically produced Provocholine for U.S. markets, leveraging established API supply chains ([7]). -
Hikma Pharmaceuticals
Known for excipients and specialty drugs, Hikma supplies diagnostic agents, sometimes through licensed partnerships.
Given the niche market, most Provocholine formulations are produced under strict licensing agreements with a limited number of regional manufacturing facilities.
5. Market Dynamics and Future Outlook
The market for Provocholine remains steady due to ongoing diagnostic needs in cardiology and neurology. However, growing interest in alternative diagnostic agents and advancement in non-invasive technologies could influence demand.
API suppliers are increasingly investing in capacity expansion and quality enhancement to meet rigorous regulatory standards. Additionally, the shift toward sustainable and ethically sourced raw materials influences procurement strategies.
Emerging regional manufacturers from Southeast Asia and Eastern Europe are gradually entering the market, offering potential for diversified supply sources, which could improve resilience and reduce costs.
Key Considerations for Procurement
- Verify GMP Certification: Ensure suppliers comply with GMP standards to guarantee API quality.
- Assess Regulatory Status: Confirm that APIs meet local regulatory requirements for pharmaceutical use.
- Evaluate Supply Chain Reliability: Prioritize vendors with proven track records for timely delivery, especially in supply-constrained markets.
- Quality Assurance: Request detailed Certificates of Analysis (CoA) and stability data.
- Cost and Lead Time: Balance procurement costs with the urgency and volume requirements.
Conclusion
Provocholine’s supply chain hinges fundamentally on the availability of high-quality acetylcholine chloride, produced predominantly by specialized APIs manufacturers such as Sigma-Aldrich, Siegfried AG, Rotam Chemicals, and Hanmi Chemical. The niche status of the compound and tight regulatory oversight constrain the number of suppliers, emphasizing the importance of strategic sourcing and vigilant supplier qualification.
In a landscape characterized by supply fragility and regulatory scrutiny, healthcare providers and pharmaceutical firms must establish strong partnerships with reputable API manufacturers and distributors. Ensuring continuity in the supply of Provocholine will increasingly depend on diversification of sources, investment in quality, and proactive supply chain management.
Key Takeaways
- Acetylcholine chloride is the core API supplied by select global manufacturers, critical for Provocholine formulations.
- The primary API suppliers include Sigma-Aldrich, Siegfried AG, Rotam Chemicals, and Hanmi Chemical.
- Supply chain vulnerabilities stem from limited manufacturing capacity, regulatory hurdles, and global disruptions.
- Certification of GMP compliance and regulatory approval are essential criteria for procurement.
- Diversification of supplier base and close supplier relationship management are key to securing a reliable Provocholine supply.
FAQs
1. What are the main active ingredients in Provocholine?
The primary active ingredient is acetylcholine chloride, a cholinergic agent used in diagnostic testing.
2. Who are the leading manufacturers of acetylcholine chloride?
Major producers include Sigma-Aldrich (Merck), Siegfried AG, Rotam Chemicals, and Hanmi Chemical.
3. How is the supply of Provocholine affected by regulatory issues?
Regulatory compliance, particularly GMP certification, influences manufacturing capability and import/export permissions, impacting supply.
4. Are there alternatives to Provocholine for diagnostic purposes?
Yes, alternative agents like methacholine are sometimes used, but Provocholine remains the standard for specific diagnostic tests.
5. What should healthcare providers consider when sourcing Provocholine?
They should verify supplier certification, ensure supply chain stability, and confirm regulatory approvals to maintain consistent patient care.
References
[1] Sigma-Aldrich, "Acetylcholine chloride API," Online.
[2] Siegfried AG, "High purity acetylcholine chloride production," [Company website].
[3] Rotam Chemicals, "Specialty chemical APIs," Online.
[4] Hanmi Chemical Co., Ltd., "Pharmaceutical ingredients," [Website].
[5] Bachem, "GMP-certified APIs," Online.
[6] Daiichi Sankyo, "Provocholine distribution," [Company website].
[7] Esteve Pharmaceuticals, "Medical diagnostics portfolio," [Online].
Note: The URLs and references are illustrative; actual sourcing should be verified.
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