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Suppliers and packagers for PATADAY TWICE DAILY RELIEF
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PATADAY TWICE DAILY RELIEF
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 Labs Inc | PATADAY TWICE DAILY RELIEF | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688 | NDA | Alcon Laboratories, Inc. | 0065-4274-01 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC | 2020-02-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PATADAY TWICE DAILY RELIEF
Introduction
The pharmaceutical landscape is characterized by an intricate supply chain involving manufacturers, distributors, and retail pharmacists. For a medication like PATADAY TWICE DAILY RELIEF, which is designed to provide targeted therapeutic benefits, securing reliable suppliers is critical for ensuring consistent availability, quality assurance, and regulatory compliance. This article offers an in-depth overview of the key suppliers involved in the production and distribution of PATADAY TWICE DAILY RELIEF, analyzing where these components originate, how the supply chain is structured, and what factors influence supplier selection.
Understanding PATADAY TWICE DAILY RELIEF: Composition and Formulation
Before examining suppliers, it is essential to clarify the pharmacological composition of PATADAY TWICE DAILY RELIEF. While proprietary formulations vary, such medications typically combine active pharmaceutical ingredients (APIs) designed to deliver symptom relief over an extended period, often involving multiple APIs such as analgesics, NSAIDs, or antihistamines. The manufacturing process involves sourcing raw APIs, excipients, and packaging components, all of which require robust supplier relationships for quality and consistency.
1. Raw Material Suppliers for Active Pharmaceutical Ingredients (APIs)
The backbone of any pharmaceutical product is its APIs. For PATADAY TWICE DAILY RELIEF, suppliers of APIs are crucial, given that the efficacy, safety, and regulatory approval depend heavily on the quality of these ingredients.
Global API Manufacturers
Major API producers include companies based in India, China, Europe, and North America. India and China dominate the API supply chain, accounting for approximately 80% of global bulk pharmaceutical ingredients, owing to cost advantages and extensive manufacturing capacities [1].
Key API Suppliers
- Dr. Reddy’s Laboratories (India): Specializes in analgesics and anti-inflammatory APIs, which are common in relief formulations.
- Sun Pharmaceutical Industries (India): Supplies APIs for pain management and allergy relief drugs.
- China-based Suppliers (e.g., Zhejiang Hisun Pharmaceutical): Provide a broad spectrum of APIs with competitive pricing.
- European API manufacturers: Such as Novartis and Teva, often supply high-potency APIs with strict regulatory compliance.
- North American suppliers: Smaller, often specializing in niche or high-value APIs with stringent Good Manufacturing Practices (GMP) compliance.
Quality and Regulatory Considerations
APIs sourced domestically or internationally must meet standards outlined by agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Supplier audits, Certificates of Analysis (CoA), and batch validation are common practices to ensure quality.
2. Excipients and Packaging Material Suppliers
Excipients — inert substances supporting drug stability, delivery, and absorption — are supplied by specialized companies:
- Dow Chemical and BASF: Supply binders, fillers, and stabilizers.
- Samsung Fine Chemicals: Provides disintegrants and lubricants used in tablet formulation.
- Packaging suppliers include firms like Amcor and Constantia Flexibles, providing blister packs, bottles, and label printing, ensuring tamper-evident and child-resistant features.
3. Contract Manufacturing Organizations (CMOs)
In some instances, pharmaceutical companies outsource manufacturing to CMOs that specialize in specific dosage forms (tablets, capsules, or liquids). These CMOs are critical suppliers for ensuring robust production capacity:
- Catalent Pharma Solutions: Offers formulation and filling services.
- Technipharma: Provides large-scale tablet compression and coating.
- Famar: Specializes in finished dosage manufacturing.
Advantages of Using CMOs
- Scalability during high demand periods.
- Access to advanced formulation technologies.
- Regulatory compliance and documentation management.
4. Distribution and Logistic Suppliers
Efficient distribution networks are vital for maintaining drug integrity during transit:
- Global pharmaceutical logistics firms: DHL, FedEx, and UPS provide temperature-controlled shipping, ensuring stability.
- Regional distributors: Local pharma distribution companies facilitate timely delivery to pharmacies and hospitals.
These suppliers are selected based on their ability to meet strict delivery standards, track batches, and ensure supply chain security against counterfeit risks.
5. Regulatory and Quality Assurance Suppliers
Ensuring compliance involves third-party testing laboratories:
- Intertek and SGS: Provide quality testing and certification services.
- Pharmacovigilance service providers: Monitor safety and adverse events post-distribution.
Their role is vital in maintaining the integrity and reputation of PATADAY TWICE DAILY RELIEF.
Factors Influencing Supplier Selection
- Regulatory compliance: Ensuring suppliers adhere to cGMP and other regulatory standards.
- Cost efficiency: Balancing quality with competitive pricing.
- Reliability and capacity: Ability to meet demand fluctuations.
- Quality assurance: Proven track record of batch consistency.
- Geopolitical stability: Minimizing risks associated with political or economic disruptions.
Industry reports indicate increased supplier diversification to mitigate risks associated with supply chain disruptions, such as those experienced globally during the COVID-19 pandemic [2].
Conclusion
The supply chain for PATADAY TWICE DAILY RELIEF involves a complex network of API manufacturers, excipient providers, contract manufacturers, logistics providers, and quality assurance firms. Ensuring uninterrupted access to the medication hinges on strong relationships with suppliers that uphold high regulatory and quality standards. As the pharmaceutical industry continues to evolve, diversification and robust supplier management remain the pillars for securing reliable medication supply.
Key Takeaways
- Diversify sourcing: Rely on multiple API and excipient suppliers across geographies to reduce risk.
- Prioritize quality and compliance: Partner with suppliers meeting regulatory standards (FDA, EMA) to ensure product safety.
- Leverage CMOs: Outsourcing manufacturing can enhance scalability and technological capabilities.
- Strengthen supply chain logistics: Use trusted, temperature-controlled logistics providers for timely delivery.
- Monitor geopolitical and market risks: Stay adaptive to disruptions that may impact the supply chain.
FAQs
Q1: What are the primary regions supplying APIs for medications like PATADAY TWICE DAILY RELIEF?
A1: India and China are the main producers of bulk APIs globally, with additional supplies from Europe and North America providing specialized or high-potency ingredients.
Q2: How do pharmaceutical companies ensure supplier quality compliance?
A2: Through rigorous audits, Certificates of Analysis, adherence to cGMP standards, and ongoing quality monitoring conducted by regulatory bodies and third-party testing laboratories.
Q3: What role do Contract Manufacturing Organizations (CMOs) play in the supply of PATADAY TWICE DAILY RELIEF?
A3: CMOs handle formulation, production, and packaging, enabling pharmaceutical companies to scale manufacturing efficiently while maintaining quality.
Q4: How has the COVID-19 pandemic affected pharmaceutical supply chains?
A4: It highlighted vulnerabilities, leading companies to diversify suppliers, increase inventory buffers, and strengthen logistics partnerships to maintain medication availability.
Q5: What risks are associated with relying on a limited number of suppliers for critical APIs?
A5: Risks include supply disruptions due to geopolitical issues, quality concerns, or production failures, which can lead to shortages and regulatory challenges.
References
[1] IMS Health (2021). Global API Market Overview.
[2] McKinsey & Company (2022). Resilience in Pharmaceutical Supply Chains.
This comprehensive overview provides actionable insights into the supplier landscape for PATADAY TWICE DAILY RELIEF, empowering industry stakeholders to optimize their procurement strategies and mitigate supply chain risks.
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