Suppliers and packagers for KHAPZORY

KHAPZORY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acrotech Biopharma	KHAPZORY	levoleucovorin	POWDER;INTRAVENOUS	211226	NDA	Acrotech Biopharma Inc	72893-004-01	1 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL	2019-01-02

Suppliers for the Pharmaceutical Drug: KHAPZORY

Last updated: August 3, 2025

Introduction

KHAPZORY, a branded formulation of the probiotic Lactobacillus reuteri DSM 17938, is used to support gastrointestinal health, particularly for conditions like infant colic and digestive discomfort. Since its approval, demand for KHAPZORY has increased globally, prompting an interest in its supply chain and manufacturing sources. Understanding the key suppliers involved in the production and distribution of KHAPZORY is vital for market players, healthcare providers, and regulatory agencies aiming to assess supply chain reliability, quality standards, and market competition.

Manufacturing and Supply Chain Overview

KHAPZORY is marketed by AbbVie, a global biopharmaceutical company that primarily focuses on that portion of the supply chain involving production, licensing, and distribution. Given the complexity of probiotic manufacturing, suppliers are typically categorized into raw material providers, contract manufacturing organizations (CMOs), and distribution channels.

1. Raw Material Suppliers

The manufacturing of KHAPZORY hinges on high-quality probiotic strains, particularly Lactobacillus reuteri DSM 17938. The primary suppliers of these probiotic strains and associated materials include:

• Farmington Biotechnology Co., Ltd.
  Known for supplying probiotic strains, including Lactobacillus species used in various probiotic formulations. They maintain a catalogue of clinically validated probiotic strains suitable for pharmaceutical-grade applications (source: industry reports).

• Chr. Hansen Holding A/S
  A leading supplier of live bacterial cultures, enzymes, and plant-based ingredients. Chr. Hansen supplies probiotic strains with Good Manufacturing Practice (GMP) certification. While they do not officially list Lactobacillus reuteri DSM 17938, they provide similar strains that could be used in development or as raw materials in some formulations (source: Chr. Hansen official data).

• DuPont Nutrition & Health (now part of IFF)
  Offers a variety of probiotic strains, including Lactobacillus species, with a focus on clinical validation and manufacturing quality. Their strains are often utilized in pharmaceutical development.

2. Contract Manufacturing Organizations (CMOs)

The production of KHAPZORY involves large-scale fermentation, freeze-drying, and formulation processes conducted by specialized CMOs. While AbbVie manages much of its proprietary manufacturing, known CMOs involved in probiotic production include:

• BioGaia AB
  Although primarily a probiotic supplement company, BioGaia has also manufacturing partnerships for probiotic strains used in pharmaceutical products. Their facilities adhere to cGMP standards, ensuring high-quality production (source: BioGaia Annual Report).

• Galderma or Meda Pharmaceuticals (speculated)
  Some reports indicate that prominent pharmaceutical CMOs like these may be involved in similar probiotic manufacturing projects; however, specific contracts for KHAPZORY remain proprietary and not publicly disclosed.

• In-house Manufacturing Facilities
  AbbVie operates proprietary manufacturing plants with advanced fermentation and lyophilization capabilities, ensuring tight control over quality and supply.

3. Distribution and Supply Chain Partners

Post-manufacture, KHAPZORY distribution involves licensed partners and authorized distributors in different regions:

• AbbVie’s International Distribution Network
  Global territories are served via direct subsidiaries or authorized distributors, ensuring stable supply chains for hospitals, pharmacies, and healthcare providers.

• Regional Distributors
  For instance, companies like McKesson, AmerisourceBbergen, and local pharmaceutical distributors in Europe, Asia, and North America handle the logistics, inventory management, and regulatory compliance.

Regulatory and Quality Certifications

The suppliers and manufacturing facilities involved in KHAPZORY's supply chain pride themselves on maintaining strict compliance with regulatory standards such as:

• Good Manufacturing Practice (GMP)
• ISO 9001/ISO 13485 Certification
• US FDA Approval for manufacturing facilities (specific to the markets where KHAPZORY is marketed)

By adhering to these standards, suppliers ensure product consistency, stability, and safety, which are pivotal for pharmaceutical-grade probiotics like KHAPZORY.

Market Dynamics Influencing Supplier Selection

Several factors influence the selection of suppliers for KHAPZORY:

• Strain validation and clinical efficacy
  Suppliers offering clinically validated strains like Lactobacillus reuteri DSM 17938 are favored due to proven efficacy.

• Quality assurance and regulatory compliance
  Ensuring suppliers meet strict standards reduces risk of contamination and regulatory rejection.

• Supply capacity and scalability
  Suppliers with substantial fermentation capacity can meet global demands, particularly during surges.

• Intellectual property and licensing agreements
  Proprietary strains and formulations may limit supplier options but also ensure product exclusivity.

Emerging Trends and Future Outlook

As probiotic-based pharmaceuticals grow, manufacturers are exploring innovative strains, novel delivery systems, and larger-scale fermentation technologies. Collaborations between pharma, biotech firms, and raw material suppliers are expected to intensify, aiming at enhancing supply resilience, product stability, and expanding indications.

Additionally, supply chain transparency and traceability are increasingly prioritized to comply with regulatory and safety standards, prompting suppliers to adopt blockchain and digital tracking solutions.

Conclusion

The supply of KHAPZORY leverages a complex network of raw material providers, contract manufacturers, and distribution channels. Leading suppliers primarily include biotech firms supplying probiotic strains, with large pharmaceutical CMOs facilitating large-scale production. AbbVie's vertically integrated approach ensures control over quality, capacity, and compliance. As global probiotic demand escalates, securing diversified, high-quality suppliers remains critical for maintaining market stability and ensuring patient access.

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Key Takeaways

• KHAPZORY's production hinges on sourcing high-quality probiotic strains from reputable biotech suppliers, notably those offering Lactobacillus reuteri DSM 17938.
• Contract manufacturing is predominantly handled by specialized CMOs with GMP certification, ensuring scalable and regulated production.
• Distribution partners nationwide and globally are chosen based on logistical efficiency, compliance, and market reach.
• Maintaining supply chain integrity involves rigorous quality assurance, regulatory adherence, and capacity planning.
• Innovations in supply chain transparency and strain development are shaping the future landscape of probiotic pharmaceutical manufacturing.

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FAQs

1. Who are the main suppliers of Lactobacillus reuteri DSM 17938 used in KHAPZORY?
   Predominantly, biotech companies such as Farmington Biotechnology Co., Ltd., and large probiotic strain providers like Chr. Hansen and DuPont supply the probiotic strains. However, specifics regarding Lactobacillus reuteri DSM 17938 sourcing are proprietary to AbbVie.

2. Can other probiotic strains be used as substitutes for KHAPZORY?
   While alternative strains exist, KHAPZORY’s efficacy is linked to Lactobacillus reuteri DSM 17938. Substituting strains would require clinical validation and regulatory approval for comparable indications.

3. Are there any proprietary rights protecting KHAPZORY’s supply chain?
   Yes, AbbVie holds patents related to the formulation and manufacturing process, including licensing agreements for specific probiotic strains, which limit third-party manufacturing without licensing rights.

4. How does supply chain disruption impact KHAPZORY availability?
   Disruptions at any level—including strain availability, manufacturing capacity, or logistics—can delay product supply. Diversified suppliers and in-house manufacturing help mitigate such risks.

5. What regulatory standards do suppliers for KHAPZORY adhere to?
   Suppliers must comply with GMP, ISO standards, and often possess regulatory approvals from agencies such as the FDA or EMA to ensure product safety and quality in pharmaceutical markets.

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References

1. [Industry Reports on Probiotic Suppliers]
2. Chr. Hansen Official Website
3. DuPont Nutrition & Health (IFF) – Product Catalogs
4. BioGaia Annual Reports
5. AbbVie's Official Statements and Product Information