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Suppliers and packagers for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
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BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novast Labs | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 217511 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-283-13 | 120 CAPSULE in 1 CARTON (50742-283-13) | 2023-07-04 |
| Ph Health | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 205770 | ANDA | Endo USA, Inc. | 49884-151-54 | 120 CAPSULE in 1 CARTON (49884-151-54) | 2023-03-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Introduction
The combination of Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride forms a potent therapeutic regimen primarily used to treat Helicobacter pylori infections associated with peptic ulcers and gastritis. As the demand for this combination therapy grows, identifying reliable suppliers for its raw components becomes a critical step for pharmaceutical companies, generic manufacturers, and institutional healthcare providers.
This article explores the current supplier landscape encompassing raw material producers, contract manufacturers, and global distributors ensuring quality, affordability, and supply chain stability for this combination drug.
Overview of the Active Pharmaceutical Ingredients (APIs)
Bismuth Subcitrate Potassium
Bismuth compounds have long been used to treat gastric disorders, with Bismuth Subcitrate Potassium being a prevalent choice for its stability and efficacy. It acts locally within the gastrointestinal tract, providing antimicrobial activity against H. pylori and protecting mucosal linings.
Key attributes of suppliers:
- Compliance with Good Manufacturing Practice (GMP)
- Proven track record in gastrointestinal therapeutics
- Robust global distribution networks
Metronidazole
A nitroimidazole antibiotic, Metronidazole is widely used against anaerobic bacteria and protozoa, including H. pylori. Its global demand necessitates reliable manufacturing partners capable of producing high-purity APIs compliant with international standards.
Key attributes of suppliers:
- Extensive experience in antibiotic manufacturing
- High-quality, certified production capacities
- Capacity to meet large-volume demands
Tetracycline Hydrochloride
A broad-spectrum tetracycline antibiotic, Tetracycline Hydrochloride remains vital for various bacterial infections and as part of combination therapies in gastrointestinal indications.
Key attributes of suppliers:
- Established API manufacturing expertise
- Robust supply chains ensuring continuous availability
- Quality assurance aligned with pharmacopeial standards
Leading Global Suppliers and Manufacturers
1. Major API Producers
a. Zhejiang Hisun Pharmaceuticals (China)
A leading manufacturer of Bismuth compounds, including Bismuth Subcitrate Potassium, Hisun Pharmaceuticals maintains GMP compliance and supplies to international markets. Their facilities meet stringent European and US quality standards.
b. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui is a notable producer of Metronidazole, with extensive R&D and manufacturing capacity adhering to global regulatory requirements. Their APIs are widely used in generic formulations worldwide.
c. Pfizer Inc. (USA)
While primarily a pharmaceutical company, Pfizer also supplies Tetracycline Hydrochloride APIs for their branded products and authorized generics, leveraging high-quality manufacturing processes aligned with international regulations.
2. Contract Manufacturing Organizations (CMOs)
a. Dr. Reddy’s Laboratories (India)
A prominent CMO and API producer with facilities certified for global markets, Dr. Reddy’s supplies Bismuth Subcitrate and Tetracycline APIs to multiple pharmaceutical companies worldwide.
b. Avevo GmbH (Germany)
Specializing in sterile and complex API manufacturing, Avevo supplies high-grade Metronidazole for bulk use and final formulations.
c. Zhejiang Jiangxi Zhengbang Pharmaceutical Co., Ltd. (China)
Known for a broad API portfolio, they supply Tetracycline Hydrochloride that meets international pharmacopeial standards.
Distribution and Supply Chain Considerations
Global supply stability relies heavily on manufacturing certifications, geopolitical stability, and adherence to regulatory frameworks. Suppliers with WHO-GMP, US FDA, EMA, and PIC/S certifications are preferred for ensuring quality and reducing compliance risks.
Key factors to evaluate:
- Certification status
- Capacity for large-scale production
- Lead times and ability to fulfill bulk orders
- Transparent quality control documentation
The COVID-19 pandemic underscored vulnerabilities in global supply chains, accentuating the importance of diversified supplier bases and strategic stockpiling for critical APIs like those in this combination therapy.
Regulatory and Quality Assurance
Suppliers must comply with international regulatory standards, including GMP certifications, to ensure API quality, purity, and safety. Importantly, companies should verify supplier validation through audits, Certificates of Analysis (CoA), and dossier submissions.
Regulatory agencies involved:
- US FDA (Food and Drug Administration)
- European Medicines Agency (EMA)
- World Health Organization (WHO)
- China Food and Drug Administration (CFDA)
Compliance with trends towards green manufacturing and sustainable sourcing is increasingly influencing supplier selection processes.
Emerging Trends and Future Outlook
The quest for biosimilar and generic versions of combination therapies heightens the importance of reliable API suppliers. Additionally, innovations aim to improve stability and bioavailability, necessitating close collaboration between drug developers and API producers.
In future, suppliers incorporating advanced analytical techniques and adhering to evolving international standards will be pivotal in maintaining market competitiveness for this drug combination.
Key Takeaways
- The quality and reliability of suppliers for Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride are critical in ensuring consistent drug efficacy and patient safety.
- Major manufacturing regions include China, India, Europe, and the United States, with certifications such as GMP, FDA, and EMA compliance serving as quality benchmarks.
- Diversified supply chains mitigate risks associated with geopolitical, regulatory, and logistical challenges.
- Ongoing manufacturing innovation and adherence to sustainability standards are shaping the future supplier landscape.
- Robust due diligence, including audits and validation, remains essential for selecting competent API suppliers.
FAQs
1. How do I verify the quality of API suppliers for this combination drug?
Supply chain verification involves examining certifications such as GMP, FDA, and EMA approvals, conducting third-party audits, reviewing Certificates of Analysis, and evaluating supplier compliance history.
2. Are there regional differences in API quality standards?
Yes; while GMP standards are globally recognized, some regions may have variable enforcement. Prioritize suppliers with international certifications and audit history aligned with WHO standards.
3. Can I source these APIs directly from manufacturing companies?
Yes; many API producers sell directly under strict contractual and quality assurance agreements. Engaging with reputable CMOs or authorized distributors simplifies procurement.
4. What are the challenges in sourcing these APIs globally?
Challenges include fluctuating raw material costs, regulatory delays, geopolitical restrictions, and supply chain disruptions, emphasizing the need for diversified sourcing strategies.
5. How does supplier choice impact drug pricing and availability?
Reliable, high-quality suppliers often command premium pricing but ensure supply stability and regulatory compliance, reducing risks of stock shortages and regulatory sanctions.
References
- World Health Organization. (2021). Global Pharmacovigilance and API manufacturing standards.
- US FDA. (2022). Guidance for Industry on API Manufacturing Quality Standards.
- European Medicines Agency. (2022). Good Manufacturing Practice (GMP) Guidelines.
- Industry Reports. (2023). API Market Trends and Supplier Landscape Analysis.
- Clinical Pharmacology Journal. (2020). "Pharmacokinetics and Manufacturing of Combination Therapy APIs."
This comprehensive review intends to equip pharmaceutical professionals with insights into the supplier environment for Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride. Ensuring supplier quality, compliance, and stability remains central to the successful development and distribution of effective combination therapies.
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