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Suppliers and packagers for generic pharmaceutical drug: LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
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LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kenvue Brands | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140 | NDA | Kenvue Brands LLC | 50580-338-06 | 1 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK | 2008-07-01 |
| Kenvue Brands | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140 | NDA | Kenvue Brands LLC | 50580-338-12 | 2 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK | 2008-07-01 |
| Kenvue Brands | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140 | NDA | Kenvue Brands LLC | 50580-338-18 | 3 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACK | 2008-07-01 |
| Kenvue Brands | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140 | NDA | Kenvue Brands LLC | 50580-338-61 | 4 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK | 2008-07-01 |
| Kenvue Brands | IMODIUM MULTI-SYMPTOM RELIEF | loperamide hydrochloride; simethicone | TABLET;ORAL | 021140 | NDA | Kenvue Brands LLC | 50580-338-64 | 4 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACK | 2008-07-01 |
| Aurobindo Pharma Ltd | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211059 | ANDA | WALGREEN CO. | 0363-9606-75 | 2 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK | 2022-08-03 |
| Aurobindo Pharma Ltd | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211059 | ANDA | WALGREEN CO. | 0363-9606-76 | 4 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK | 2022-08-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE API & Formulation Suppliers
This analysis identifies key suppliers for LOPERAMIDE HYDROCHLORIDE (API) and SIMETHICONE (API), along with contract development and manufacturing organizations (CDMOs) capable of producing finished dosage forms of LOPERAMIDE HYDROCHLORIDE; SIMETHICONE combination products. The market for these APIs is characterized by established players and a moderate level of global competition. Supplier selection hinges on regulatory compliance, manufacturing capacity, quality control, and cost-effectiveness.
Who are the primary manufacturers of LOPERAMIDE HYDROCHLORIDE API?
The production of LOPERAMIDE HYDROCHLORIDE Active Pharmaceutical Ingredient (API) is concentrated among a select group of global manufacturers. These companies possess the necessary chemical synthesis capabilities and adhere to stringent Good Manufacturing Practices (GMP) required for pharmaceutical ingredient production.
| Manufacturer Name | Country of Origin | Key Markets Served | Notes |
|---|---|---|---|
| Almiral, S.A. | Spain | Global | Established producer, potential for large-scale production. |
| Cadila Healthcare Ltd. | India | Global | Strong presence in generic API manufacturing. |
| Capri Pharma Ltd. | India | Global | Focus on diverse therapeutic areas, including GI. |
| Chemi-Pharma Intl. Corp. | United States | North America | Specializes in pharmaceutical intermediates and APIs. |
| Divi's Laboratories Ltd. | India | Global | One of the largest API manufacturers globally. |
| Granules India Ltd. | India | Global | Significant player in both API and finished dosage forms. |
| IOL Chemicals and Pharma Ltd. | India | Global | Broad API portfolio, including pain management and GI. |
| Jiangsu Haosen Pharmaceutical Group Co., Ltd. | China | Asia, Europe | Growing presence in international markets. |
| Loba Chemie Pvt. Ltd. | India | Global | Known for quality reagents and pharmaceutical ingredients. |
| Masco Group | Pakistan | Asia | Focus on APIs for various therapeutic categories. |
| Nectar Lifesciences Ltd. | India | Global | Vertically integrated operations from intermediates to APIs. |
| Sanofi S.A. | France | Global | Major pharmaceutical company with API manufacturing arm. |
| Solara Active Pharma Sciences Ltd. | India | Global | Strong R&D capabilities, focus on complex chemistry. |
| Teva Pharmaceutical Industries Ltd. | Israel | Global | World's largest generic drug manufacturer. |
What are the typical quality and regulatory standards for LOPERAMIDE HYDROCHLORIDE API?
LOPERAMIDE HYDROCHLORIDE API must meet rigorous quality and regulatory standards to ensure patient safety and product efficacy. These standards are enforced by global regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national authorities.
- Pharmacopoeial Compliance: API must conform to specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). This includes tests for identity, assay, impurities, residual solvents, and heavy metals.
- Good Manufacturing Practices (GMP): Manufacturing facilities must operate under current GMP guidelines (cGMP) as defined by regulatory agencies. This encompasses robust quality management systems, validated manufacturing processes, rigorous change control, and thorough documentation.
- Impurity Profiling: Manufacturers must identify and control all potential impurities, including related substances, process impurities, and degradation products, to levels deemed safe by regulatory authorities.
- Stability Studies: Comprehensive stability data demonstrating the API's shelf-life under defined storage conditions are mandatory.
- Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, and controls. Pharmaceutical companies reference these DMFs in their drug product applications.
Who are the key suppliers of SIMETHICONE API?
SIMETHICONE, a defoaming agent used to relieve bloating and discomfort, is produced by a different set of specialized chemical manufacturers. The synthesis of SIMETHICONE involves organosilicon chemistry.
| Manufacturer Name | Country of Origin | Key Markets Served | Notes |
|---|---|---|---|
| DOW | United States | Global | Leading producer of silicones and specialty chemicals. |
| Evonik Industries AG | Germany | Global | Broad portfolio of specialty chemicals, including silicones. |
| Momentive Performance Materials | United States | Global | Global leader in silicon-based technologies. |
| Shin-Etsu Chemical Co., Ltd. | Japan | Global | Major producer of silicones and advanced materials. |
| Wacker Chemie AG | Germany | Global | Significant player in silicones and polymers. |
| Xiameter (Dow) | United States | Global | Cost-effective silicone product line from Dow. |
| Zhongshan Xinyuan Silicone Material Co., Ltd. | China | Asia | Emerging player in the silicone market. |
What are the critical specifications for SIMETHICONE API?
SIMETHICONE API specifications focus on its physical and chemical properties that dictate its effectiveness as an antiflatulent.
- Active Content: The concentration of the active silicone polymer.
- Viscosity: A key parameter affecting its dispersibility and efficacy.
- Particle Size Distribution (if applicable for specific formulations): Can influence dissolution and bioavailability.
- Impurities: Control of residual catalysts, by-products, and heavy metals is essential.
- Stability: Resistance to degradation under normal storage and processing conditions.
- Compliance: Often specified to meet USP or EP monograph requirements.
Which CDMOs can produce LOPERAMIDE HYDROCHLORIDE; SIMETHICONE finished dosage forms?
The production of fixed-dose combination products like LOPERAMIDE HYDROCHLORIDE; SIMETHICONE requires specialized expertise in formulation development and manufacturing. Contract Development and Manufacturing Organizations (CDMOs) with experience in handling multiple APIs and complex dosage forms are crucial for pharmaceutical companies lacking in-house capacity or expertise.
The specific combination of LOPERAMIDE HYDROCHLORIDE and SIMETHICONE is commonly found in oral tablets or capsules. CDMOs offering solid dosage form manufacturing are most relevant.
| CDMO Name | Primary Location(s) | Dosage Forms Offered | Therapeutic Area Expertise | Notes |
|---|---|---|---|---|
| AAIPharma Services | United States | Tablets, Capsules, Liquids, Semi-solids | Various, including Gastrointestinal | Offers integrated services from development to commercial manufacturing. |
| Catalent Pharma Solutions | Global | Tablets, Capsules, Softgels, Liquids, Injectables | Broad, with significant GI and oral solid expertise. | One of the largest global CDMOs, with extensive technological capabilities. |
| Cerbes Group | United States, Europe | Tablets, Capsules | Broad, including Gastrointestinal | Focus on complex oral solid dosage forms. |
| CordenPharma | Global | Tablets, Capsules, Injectables, Highly Potent APIs | Broad, with specialized capabilities in certain areas. | Strong expertise in complex APIs and finished dosage forms. |
| Fareva | Global | Tablets, Capsules, Liquids, Aerosols, Semi-solids | Broad, including OTC and prescription products. | Offers a wide range of services for consumer healthcare and pharmaceutical products. |
| GVK BIO | India, Germany | Tablets, Capsules, Injectables, Lyophilized Products | Broad, with a focus on generics and biosimilars. | Known for cost-effective manufacturing and a strong regulatory track record. |
| Havelock Pharma | United States | Tablets, Capsules, Liquids | Broad, including OTC and prescription drugs. | Provides end-to-end services from formulation development to commercial supply. |
| Jubilant Biosys | India, United States | Tablets, Capsules, Injectables | Broad, with a focus on generics and complex molecules. | Vertically integrated capabilities from API to finished dosage forms. |
| Kilmer Innovative Services | United States | Tablets, Capsules, Liquids, Injectables | Broad, with particular strength in innovative formulations. | Offers specialized services for challenging formulations and drug delivery systems. |
| Patheon (part of Thermo Fisher Scientific) | Global | Tablets, Capsules, Liquids, Injectables, Biologics | Extensive, covering a vast range of therapeutic areas. | A leading global CDMO with a comprehensive suite of services and a significant manufacturing footprint. |
| Recro Pharma | United States | Tablets, Capsules, Liquids | Primarily pain management and gastrointestinal. | Specializes in oral solid dosage forms. |
| Siegfried AG | Global | Tablets, Capsules, Liquids, Injectables | Broad, with expertise in sterile and non-sterile products. | Known for its high standards in quality and regulatory compliance. |
| Sharp Packaging Solutions (part of AmerisourceBergen) | United States, Europe | Unit Dose Packaging, Blister Packaging, Bottles | N/A (primarily packaging and logistics) | Critical for the final packaging and distribution of LOPERAMIDE HYDROCHLORIDE; SIMETHICONE products. |
| Sterling Pharma Solutions | United States | Tablets, Capsules, Liquids, Semi-solids | Broad, with expertise in sterile and non-sterile products. | Focuses on providing high-quality manufacturing services for complex products. |
| WuXi AppTec | Global | Tablets, Capsules, Injectables, Biologics, Gene/Cell Therapy | Comprehensive, covering all stages of drug development. | A major global CDMO offering a vast array of services, including formulation and manufacturing. |
What are the key considerations for selecting a CDMO for LOPERAMIDE HYDROCHLORIDE; SIMETHICONE?
Selecting the right CDMO is critical for successful product launch and sustained supply. Key considerations include:
- Regulatory Compliance: The CDMO must have a strong history of successful regulatory inspections (FDA, EMA, etc.) and maintain cGMP compliance.
- Technical Expertise: Demonstrated experience in developing and manufacturing oral solid dosage forms, particularly those involving multiple APIs with potentially different physical properties. Knowledge of granulation, compression, and coating technologies is essential.
- Capacity and Scalability: The CDMO must possess sufficient manufacturing capacity to meet projected demand and have the ability to scale up production efficiently.
- Quality Systems: Robust quality management systems, including in-process controls, release testing, and stability programs, are paramount.
- Supply Chain Integration: The ability to integrate with API suppliers and manage the overall supply chain effectively.
- Intellectual Property Protection: Strong protocols to safeguard client intellectual property.
- Cost-Effectiveness: Competitive pricing without compromising on quality or compliance.
- Communication and Project Management: Transparent communication channels and effective project management are vital for a smooth partnership.
Key Takeaways
The supply chain for LOPERAMIDE HYDROCHLORIDE and SIMETHICONE APIs involves established global manufacturers, primarily from India, Europe, and the United States. Ensuring API quality requires adherence to pharmacopoeial standards and cGMP. For finished dosage forms, a selection of experienced CDMOs globally offer manufacturing capabilities for oral solid dosage products. CDMO selection should prioritize regulatory track record, technical expertise in solid dosage forms, capacity, and robust quality systems.
Frequently Asked Questions
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Are there any patent expiries for LOPERAMIDE HYDROCHLORIDE that would impact the generic API market? Patent expiries for the active molecule Loperamide Hydrochloride have long passed, allowing for broad generic API manufacturing. However, specific patents related to novel formulations, manufacturing processes, or combination products could still be in force. A thorough patent landscape analysis is recommended for specific market entry.
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What are the typical lead times for sourcing LOPERAMIDE HYDROCHLORIDE and SIMETHICONE APIs? Lead times can vary significantly based on the supplier's inventory, current production schedules, and order volume. Generally, for established APIs, lead times can range from 4 to 12 weeks. Urgent or custom orders may incur longer lead times and potentially higher costs.
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Does the combination of LOPERAMIDE HYDROCHLORIDE and SIMETHICONE present unique formulation challenges? Yes, the combination can present challenges. Loperamide Hydrochloride is a relatively stable molecule, while Simethicone is an organosilicon polymer. Ensuring uniform dispersion and stability of both active ingredients within a solid dosage form, especially at low concentrations for Simethicone, requires careful formulation development and process control. Compatibility studies between the two APIs and excipients are essential.
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What regulatory hurdles are specific to manufacturing fixed-dose combination products like LOPERAMIDE HYDROCHLORIDE; SIMETHICONE? Regulatory bodies scrutinize fixed-dose combinations for therapeutic rationale (i.e., do the two drugs offer a benefit together that is greater than their individual use or are they synergistic?). Demonstration of the safety and efficacy of the combination, as well as ensuring that the manufacturing process adequately controls the content and uniformity of both APIs, are key regulatory requirements.
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Can a single CDMO reliably manufacture both APIs and the finished dosage form? While some large, vertically integrated pharmaceutical companies may have this capability, it is uncommon for a single CDMO to manufacture both highly specialized APIs (Loperamide HCl and Simethicone) and the finished drug product. API manufacturing requires distinct chemical synthesis facilities and expertise compared to finished dosage form manufacturing. Pharmaceutical companies typically source APIs from dedicated API manufacturers and engage a CDMO for formulation and finished product manufacturing.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from [FDA website] [2] European Medicines Agency. (n.d.). Guidance Documents. Retrieved from [EMA website] [3] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from [USP website] [4] European Pharmacopoeia. (n.d.). Ph. Eur. Online. Retrieved from [Ph. Eur. website]
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