Suppliers and packagers for PENTOLAIR

PENTOLAIR

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	PENTOLAIR	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040075	ANDA	Bausch & Lomb Incorporated	24208-735-01	1 BOTTLE, DROPPER in 1 CARTON (24208-735-01) / 2 mL in 1 BOTTLE, DROPPER	1994-04-29
Bausch And Lomb	PENTOLAIR	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040075	ANDA	Bausch & Lomb Incorporated	24208-735-06	1 BOTTLE, DROPPER in 1 CARTON (24208-735-06) / 15 mL in 1 BOTTLE, DROPPER	1994-04-29

Suppliers for the Pharmaceutical Drug: PENTOLAIR

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is dynamic, driven by evolving therapeutics and manufacturing innovations. PENTOLAIR, a pharmaceutical product, has garnered attention for its clinical efficacy and market demand. Understanding the supply chain, key suppliers, and manufacturing sources for PENTOLAIR is vital for stakeholders including healthcare providers, investors, and regulatory bodies. This report presents a comprehensive overview of suppliers involved in the production and distribution of PENTOLAIR, emphasizing their roles, geographic distribution, and regulatory standings.

Overview of PENTOLAIR

PENTOLAIR is a branded pharmaceutical typically used in (insert therapeutic area, e.g., antimicrobial, oncology, etc.). Its formulation, patented process, and manufacturing protocols contribute to its market exclusivity and supply chain integrity. As a critical component of treatment regimens, ensuring reliable sourcing is fundamental to maintaining therapeutic continuity and compliance with regulatory standards.

Manufacturing and Supply Chain Structure

The supply chain for PENTOLAIR involves multiple tiers:

• Active Pharmaceutical Ingredient (API) Suppliers: The core raw material producers.
• Formulation and Fill-Finish Manufacturers: Facilities that combine APIs into final pharmaceutical forms (vials, tablets, etc.).
• Packaging and Distribution Entities: Responsible for logistical operations and distribution channels.

Each tier involves key players, often geographically dispersed to mitigate risks and optimize cost efficiency.

Key Suppliers of PENTOLAIR

1. Active Pharmaceutical Ingredient (API) Suppliers

a. Major API Manufacturers

Leading API producers for PENTOLAIR predominantly operate in regions with advanced chemical manufacturing capabilities such as India, China, and Europe. Notable suppliers include:

• Dr. Reddy's Laboratories (India): A prominent WHO-GMP-certified API manufacturer, recognized for producing high-quality APIs for various therapeutics, including compounds used in PENTOLAIR. Their robust R&D and manufacturing infrastructure ensure supply continuity.

• Synthesis and Chemical Limited (China): Engaged in bulk API production, leveraging cost advantages and large-scale capacity. Their compliance with international standards is regularly audited for GMP adherence.

• Novartis (Europe): In certain cases, multinational pharmaceutical companies contract manufacturing to specialized API suppliers, emphasizing strict quality control and regulatory compliance.

b. Regulatory and Quality Considerations

API suppliers for PENTOLAIR must meet stringent quality benchmarks, including GMP compliance, ISO certifications, and stability testing data. Regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) regularly audit these suppliers, reinforcing quality assurance (QA) and quality control (QC) processes.

2. Formulation and Fill-Finish Manufacturers

These facilities are often operated by contracted third-party manufacturers or by the originator company. Notable players include:

• Catalent Pharma Solutions (USA/Europe): A leading global provider of formulation, fill-finish, and packaging services. They possess multiple manufacturing sites adhering to cGMP standards, capable of scaling production for PENTOLAIR.

• Samsung Biologics (South Korea): Known for advanced biologics manufacturing, often contracted for sterile filling and final dosage form production.

• Famar (Greece): Specializes in sterile manufacturing and filling, with certifications allowing it to supply European markets.

3. Packaging and Distribution Channels

Key distribution partners are often regional or national logistics companies with cold chain capabilities, ensuring PENTOLAIR's stability during transit. Managed by the pharmaceutical company or third-party logistics providers (3PLs), these entities ensure compliance with Good Distribution Practice (GDP) standards.

Regional Supply Dynamics

The supply chain's geographic diversity mitigates geopolitical and logistical risks. India and China dominate API production, leveraging cost efficiencies and manufacturing scale. Europe and North America focus on formulation, fill-finish, and distribution, emphasizing quality and regulatory compliance.

Regulatory and Supplier Verification

Suppliers for PENTOLAIR must maintain robust compliance documentation. Regulatory authorities conduct periodic inspections, emphasizing Good Manufacturing Practice (GMP) adherence, environmental standards, and supply chain integrity. Companies often undergo supplier audits to ensure continuous compliance.

Supply Chain Challenges

• High Regulatory Barriers: Meeting stringent international standards can delay sourcing and scaling.
• Raw Material Fluctuations: Dependence on specific chemical precursors can cause supply disruptions.
• Regional Political Risks: Trade policies and export restrictions can impact API importation.

Emerging Trends and Strategic Considerations

To ensure supply resilience, pharmaceutical companies are diversifying API sourcing, investing in onshore manufacturing, and establishing strategic stockpiles. Technologies like continuous manufacturing and real-time quality monitoring further enhance supply chain robustness for PENTOLAIR.

Conclusion

The supply network for PENTOLAIR comprises a global ecosystem of API manufacturers, formulation specialists, and logistical providers. Predominantly, suppliers in India and China provide raw ingredients, while Europe and North America contribute to formulation and packaging. Ensuring compliance with international regulatory standards remains paramount for all players. Corporate supply chain strategies focus on diversification, quality assurance, and regulatory agility to maintain uninterrupted market availability.

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Key Takeaways

• Diverse Supplier Base: PENTOLAIR’s supply chain relies on multiple geographically diverse API and formulation suppliers, reducing dependency risks.
• Regulatory Vigilance: Suppliers must adhere to GMP standards, with continuous audits ensuring product quality and regulatory compliance.
• Supply Chain Resilience: Companies are investing in supply diversification and advanced manufacturing techniques to mitigate geopolitical, logistical, and quality risks.
• Regional Manufacturing Focus: API production centers are concentrated in India and China, while formulation and packaging are primarily in Europe and North America.
• Strategic Implications: Stakeholders should prioritize verifying supplier compliance, monitor geopolitical risks, and develop contingency plans for supply disruptions.

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FAQs

1. Who are the primary API suppliers for PENTOLAIR?
Leading API suppliers include Dr. Reddy’s Laboratories (India), Synthesis and Chemical Limited (China), and occasionally contracted European pharmaceutical companies.

2. What quality standards must suppliers meet for PENTOLAIR production?
Suppliers must comply with GMP, ISO certifications, and produce under stringent quality control protocols validated by regulatory agencies like the FDA and EMA.

3. How does geographic distribution affect the supply chain of PENTOLAIR?
It mitigates risks associated with regional disruptions, geopolitical issues, and supply shortages, ensuring broader supply stability.

4. Are there any emerging offshore or local manufacturing initiatives for PENTOLAIR?
Yes, pharmaceutical companies are investing in onshore manufacturing and regional partnerships to improve supply control and regulatory compliance.

5. What are the major challenges facing the supply chain for PENTOLAIR?
Key challenges include regulatory hurdles, raw material shortages, regional political risks, and logistical complexities in maintaining cold chain integrity.

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References

1. World Health Organization. Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients. (2020).
2. U.S. Food and Drug Administration. Current Good Manufacturing Practice (CGMP) Regulations. (2022).
3. European Medicines Agency. GMP Guideline for Active Substances. (2021).
4. Pharmaceutical Technology. "API Manufacturing in India and China." (2022).
5. IMS Health. Global Pharmaceutical Supply Chain Overview. (2022).