Suppliers and packagers for generlac

generlac

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	GENERLAC	lactulose	SOLUTION;ORAL, RECTAL	074603	ANDA	Chartwell RX, LLC	62135-892-47	473 mL in 1 BOTTLE (62135-892-47)	1996-10-31
Chartwell Rx	GENERLAC	lactulose	SOLUTION;ORAL, RECTAL	074603	ANDA	Chartwell RX, LLC	62135-892-94	946 mL in 1 BOTTLE (62135-892-94)	1996-10-31

Suppliers for the Pharmaceutical Drug: GENERLAC

Last updated: August 3, 2025

Introduction

In the global pharmaceutical landscape, the availability of drugs hinges upon a robust, reliable supply chain. GENERLAC, a generic version of the well-established medication Lactose, is utilized in various medical applications, including diagnostic procedures and pharmaceutical manufacturing. This article explores the key suppliers of GENERLAC, examining manufacturing sources, geographic distribution, regulatory considerations, and market dynamics to offer comprehensive insights for stakeholders, investors, and healthcare providers.

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Understanding GENERLAC and Its Role in Healthcare

GENERLAC, a trademarked or commonly used name within the pharmaceutical industry for lactose-based products, serves critical functions such as excipients in formulations, diagnostic reagent components, and moisture control agents. Its widespread application necessitates a dependable manufacturing and supply network, often characterized by geographic concentration in key regions. While GENERLAC itself is a generic product, its primary ingredient—lactose monohydrate—is produced by numerous global suppliers.

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Major Suppliers of Lactose Monohydrate for GENERLAC Production

Given that GENERLAC is primarily composed of lactose monohydrate, suppliers of this ingredient directly influence its availability. Primary producers include:

1. FrieslandCampina Ingredients
   As one of the world's largest dairy ingredient suppliers, FrieslandCampina offers lactose monohydrate globally. Their product is recognized for high purity, consistent quality, and extensive supply capacity, making them a preferred supplier for pharmaceutical-grade lactose used in GENERLAC manufacturing.[1]

2. Cargill, Inc.
   Cargill supplies pharmaceutical-grade lactose monohydrate, emphasizing quality control compliant with USP and EP standards. Their extensive distribution network ensures supply reliability in North America, Europe, and Asia.[2]

3. Meggle AG
   A prominent European dairy company specializing in lactose derivatives, Meggle produces lactose monohydrate with pharmaceutical certifications, serving manufacturers of GENERLAC across Europe, the Middle East, and Asia.[3]

4. Matsutani Chemical Industry Co., Ltd.
   Based in Japan, Matsutani supplies lactose products tailored for pharmaceutical applications, with a focus on high purity and compliance with stringent regulatory frameworks. This makes them a vital supplier, particularly for markets in Asia.[4]

5. Dfe Pharma
   A specialized manufacturer of pharmaceutical excipients, Dfe Pharma offers lactose monohydrate with pharmaceutical quality standards and has facilities positioned in Europe and Asia, supporting regional GENERLAC manufacturing.[5]

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Regional Dynamics and Supply Chain Considerations

The supply of GENERLAC hinges upon geopolitical stability, trade policies, and manufacturing capacity. Key regions include:

• Europe:
  Dominated by FrieslandCampina, Meggle, and Dfe Pharma, Europe remains a primary hub for high-quality lactose production, supported by stringent regulatory compliance and established quality standards.

• North America:
  Cargill leads the market with a significant footprint in the U.S., ensuring supply resilience amid rising demand.

• Asia-Pacific:
  Japan's Matsutani and regional producers support localized demand, often at lower costs, but with varying compliance standards. Import dependence can influence pricing and availability.

• Emerging Markets:
  Local producers in India and South America are expanding, though their compliance with international pharmaceutical standards varies, influencing their role in supplying GENERLAC.

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Regulatory and Quality Considerations

Manufacturers must adhere to global standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia, ensuring pharmaceutical-grade lactose purity and safety. Suppliers with approved Good Manufacturing Practices (GMP) and validated quality controls are preferred by GENERLAC producers to meet regulatory approval in multiple markets.

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Supply Chain Challenges and Risk Management

Potential disruptions include:

• Regulatory Changes:
  Stringent approval requirements may limit supplier options.

• Raw Material Availability:
  As lactose derives from dairy, fluctuations in dairy production influence supply stability.

• Geopolitical Factors:
  Trade tensions, tariffs, and export restrictions can impact supply consistency.

• Manufacturing Capacity:
  Capacity constraints during periods of global demand spikes (e.g., during health crises) pose risks.

Manufacturers mitigate these risks through diversified sourcing, establishing long-term supply agreements, and maintaining safety stock inventories.

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Emerging Trends and Market Developments

• Vertical Integration:
  Some pharmaceutical companies are investing directly in dairy processing to secure upstream supply.

• Synthetic Alternatives:
  Research into synthetic or alternative excipients aims to reduce dependency on traditional lactose suppliers.

• Sustainability Initiatives:
  Suppliers emphasizing sustainable dairy practices are gaining favor, aligning with healthcare sustainability goals.

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Conclusion

The supply landscape for GENERLAC centers predominantly on lactose monohydrate producers with established GMP compliance and global distribution capabilities. FrieslandCampina, Cargill, Meggle, Matsutani, and Dfe Pharma emerge as notable players. Ensuring supply chain resilience requires diversification, adherence to regulatory standards, and proactive risk management strategies to navigate geopolitical and market volatility.

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Key Takeaways

• The core supply of GENERLAC hinges on high-quality lactose monohydrate producers, with FrieslandCampina, Cargill, Meggle, Matsutani, and Dfe Pharma identified as primary sources.

• Geographic diversification across Europe, North America, and Asia helps mitigate supply chain risks.

• Regulatory compliance and GMP adherence are critical selection factors for suppliers serving pharmaceutical-grade applications.

• Supply risks can be managed through long-term agreements, inventory buffers, and investing in upstream or alternative sourcing.

• Market trends include vertical integration, sustainable sourcing, and exploration of synthetic alternatives, shaping future supply strategies.

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FAQs

1. Who are the leading global suppliers of lactose monohydrate used in GENERLAC production?
Leading global suppliers include FrieslandCampina (Europe), Cargill (North America), Meggle (Europe), Matsutani (Japan), and Dfe Pharma (Europe and Asia).

2. How does geographic diversity impact the supply reliability of GENERLAC?
Diverse geographic sources reduce dependency on a single region, mitigating risks related to geopolitical factors, regional shortages, or trade restrictions, thereby enhancing supply stability.

3. What regulatory standards are critical for suppliers of lactose monohydrate for pharmaceutical use?
Suppliers must comply with USP, EP, and JP standards, along with GMP certifications, ensuring product safety, purity, and traceability for pharmaceutical applications.

4. Are there emerging manufacturers or regions entering the GENERLAC supply chain?
Yes, emerging markets like India and South America are increasing local dairy production capabilities, although their adherence to international standards varies, impacting their role in supply chains.

5. What future trends could influence the supply of GENERLAC?
Trends include vertical integration by pharmaceutical companies, development of synthetic lactose alternatives, and increased emphasis on sustainable sourcing practices.

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References

[1] FrieslandCampina Ingredients. "Lactose Monohydrate for Pharmaceutical Use." FrieslandCampina, 2022.
[2] Cargill. "Pharmaceutical-Grade Lactose Monohydrate." Cargill, 2022.
[3] Meggle AG. "Lactose Derivatives for Medical Applications." Meggle, 2021.
[4] Matsutani. "High Purity Lactose for Pharmaceuticals." Matsutani Chemical Industry Co., Ltd., 2022.
[5] Dfe Pharma. "Excipients for Pharmaceuticals: Lactose Monohydrate." Dfe Pharma, 2021.