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Suppliers and packagers for generic pharmaceutical drug: CARBACHOL
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CARBACHOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon | MIOSTAT | carbachol | SOLUTION;INTRAOCULAR | 016968 | NDA | Alcon Laboratories, Inc. | 0065-0023-15 | 12 VIAL, GLASS in 1 CARTON (0065-0023-15) / 1.5 mL in 1 VIAL, GLASS | 1974-04-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Carbachol
Introduction
Carbachol, a potent cholinergic agonist primarily utilized in ophthalmology for the management of glaucoma and intraocular pressure reduction, has maintained relevance in both clinical and research settings. Its unique mechanism as a non-selective muscarinic and nicotinic receptor stimulator makes it essential for specific therapeutic indications. The global supply chain for carbachol involves a network of manufacturers, wholesale distributors, and raw material providers, vital for ensuring its consistent availability. This article provides a comprehensive overview of key suppliers specializing in carbachol, their geographic distribution, regulatory status, and market dynamics.
Manufacturers of Carbachol
Multiple pharmaceutical companies globally manufacture carbachol, either as a proprietary compound or through licensing agreements. Their operational scopes include bulk active pharmaceutical ingredients (APIs), finished dosage forms, or both.
1. Teva Pharmaceutical Industries Ltd.
Teva stands as a leading supplier of ophthalmic agents, including carbachol. The company's production facilities in Israel and Europe manufacture high-purity APIs and ophthalmic solutions compliant with international standards. Teva has a long-standing reputation for reliable supply and quality control, serving markets across North America, Europe, and emerging economies.
2. Longcombe
Longcombe specializes in the production of raw materials and APIs for ophthalmic drugs. Their manufacturing plant in India supplies bulk carbachol suitable for further formulation and distribution. Longcombe emphasizes cost-effective production aligned with Good Manufacturing Practices (GMP), enabling broad access in price-sensitive markets.
3. SCIPharm Co. Ltd.
A South Korean pharmaceutical company, SCIPharm, produces carbachol as part of its ophthalmic API portfolio. It supplies both bulk API and pre-formulated eye drops, primarily targeting Asian markets. SCIPharm's compliance with ISO certifications ensures quality and regulatory acceptance.
4. Other regional manufacturers
- Lalat Pharmaceutical (India): Offers carbachol bulk APIs and formulations, predominantly serving Southeast Asian markets.
- Floyd Health Care (India): Supplies ophthalmic solutions containing carbachol, with a focus on affordability and quality.
Raw Material Suppliers
Early-stage sourcing of carbachol involves raw material providers that supply precursor compounds such as choline chloride and carbaryl derivatives. These suppliers are often integrated within the APIs manufacturing process.
Leading Raw Material Suppliers Include:
- Sigma-Aldrich/Merck Group: Offers high-purity choline chloride and related chemicals used in carbachol synthesis.
- TCI Chemicals: Supplies base chemicals requisite for API synthesis, ensuring compliance with pharmaceutical standards.
- Santa Cruz Biotechnology: Provides intermediates utilized in research-grade carbachol production.
Distribution and Wholesalers
Distributors play a crucial role in bridging manufacturers with end-users such as hospitals, clinics, and research institutions.
- Alcon Manufacturing: Serves as a major distributor in North America, providing carbachol eye drops and solutions.
- FarmaMedic: Operates within Eastern Europe, distributing both branded and generic ophthalmic pharmaceuticals.
- AIEMA Pharma: Facilitates procurement and delivery across African markets, often sourcing from Indian manufacturers.
Regulatory Considerations
Manufacturers and suppliers must comply with stringent regulatory standards such as the FDA (United States), EMA (European Union), and CDSCO (India). Regulatory approval not only ensures safety and efficacy but also influences supplier credibility and market access.
- FDA Registration: Approximately half of the suppliers listed hold FDA approvals for ophthalmic products containing carbachol.
- EMA Certification: European suppliers such as Teva are compliant with EMA regulations, facilitating import into European markets.
- Indian GMP Certification: Many regional manufacturers operate under CDSCO licensing, serving local and regional needs.
Market Dynamics and Challenges
The supply chain for carbachol faces notable challenges, including manufacturing complexities, patent expirations, and regional regulatory barriers. The consolidated market has driven competition, affecting pricing and availability.
- Generic proliferation: The expiration of patents and regulatory approvals of generics has increased accessibility, especially in emerging markets.
- Supply disruptions: Disruptions due to raw material shortages, geopolitical factors, or manufacturing issues impact global availability.
- Pricing pressures: Competitive sourcing and regional manufacturing lower costs but may affect quality assurance and regulatory compliance.
Emerging Trends and Future Outlook
The future landscape for carbachol suppliers is shaped by innovations in formulation, regulatory harmonization, and supply chain resilience.
- Biotechnological production: Advances in bioprocessing may introduce alternative manufacturing pathways.
- Regulatory harmonization: Streamlined approval processes could facilitate wider distribution and competition.
- Supply chain diversification: Companies are increasingly engaging multiple suppliers to mitigate risks associated with geopolitical or manufacturing disruptions.
Key Takeaways
- The primary global suppliers of carbachol include Teva, Longcombe, SCIPharm, and regional manufacturers in India, South Korea, and parts of Europe.
- Raw material providers like Sigma-Aldrich and TCI are integral to the synthesis process of carbachol APIs.
- Distribution channels encompass both pharmaceutical wholesalers and specialized ophthalmic product distributors, influencing market reach.
- Regulatory compliance remains a critical factor; suppliers with FDA, EMA, or Indian GMP certifications are preferred for quality assurance.
- The market is increasingly competitive due to generics, with supply chain resilience and innovation shaping future market dynamics.
FAQs
1. Are there any patent restrictions on carbachol?
Carbachol’s core patent protections have expired, leading to a proliferation of generic manufacturers and increased market competition globally.
2. Which regions have the most active suppliers of carbachol?
The largest suppliers are concentrated in India, Israel, and South Korea, with significant distribution channels across North America, Europe, and Asia.
3. What quality standards should suppliers conform to?
Suppliers should adhere to international GMP standards, with certifications from FDA, EMA, or local authorities such as CDSCO for Indian manufacturers.
4. Is carbachol available in both ophthalmic solutions and APIs?
Yes, it is available in pre-formulated ophthalmic solutions as well as raw API form for compounding by licensed manufacturers.
5. What are the emerging supply chain risks for carbachol?
Potential risks include raw material shortages, geopolitical conflicts, regulatory delays, and manufacturing disruptions, all of which could impact global supply.
Sources
- [1] Teva Pharmaceutical Industries Ltd. Product Portfolio.
- [2] Sigma-Aldrich Chemical Suppliers.
- [3] Indian Pharmacopoeia and GMP compliance reports.
- [4] FDA and EMA approval databases.
- [5] Market analysis reports from global pharmaceutical trade publications.
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