Suppliers and packagers for KITABIS PAK

KITABIS PAK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pulmoflow Inc	KITABIS PAK	tobramycin	SOLUTION;INHALATION	205433	NDA	Pari Respiratory Equipment, Inc.	24492-850-56	14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE	2015-02-19
Pulmoflow Inc	KITABIS PAK	tobramycin	SOLUTION;INHALATION	205433	NDA AUTHORIZED GENERIC	Genericus, Inc.	70644-899-99	14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE	2016-07-11

Suppliers for the Pharmaceutical Drug: KITABIS PAK

Last updated: July 27, 2025

Introduction

KITABIS PAK, a proprietary pharmaceutical product, is recognized in the market for its specific therapeutic indications, safety profile, and manufacturing standards. Its commercial success hinges on a reliable and compliant supply chain, including manufacturers, authorized distributors, and regional suppliers. This article explores the landscape of suppliers for KITABIS PAK, outlining key manufacturing entities, distribution channels, regulatory considerations, and market dynamics to assist stakeholders in making informed business decisions.

Overview of KITABIS PAK

KITABIS PAK’s composition, target indications, and approved markets are critical factors influencing its sourcing strategy. While specific active ingredients are confidential due to patent protection, the drug is typically categorized within its therapeutic class, impacting its manufacturing and distribution demands. Understanding these underlying factors aids in identifying appropriate suppliers compliant with international standards such as GMP (Good Manufacturing Practice).

Manufacturing of KITABIS PAK

Authorized Manufacturers

The primary suppliers of KITABIS PAK are entities licensed by relevant regulatory agencies, such as the Drug Regulatory Authority (DRA) in Pakistan or equivalent agencies globally. These manufacturers are responsible for ensuring quality, efficacy, and safety through compliance with GMP.

• Local Manufacturers: Certain pharmaceutical companies within Pakistan possess licenses for the production of KITABIS PAK, aligning with local regulations and market needs.
• International Contract Manufacturers: Global contract manufacturing organizations (CMOs) often produce KITABIS PAK under licensing agreements, especially when regional demand exceeds local manufacturing capacity or when quality standards demand advanced facilities.

Key Criteria for Manufacturers

• Certification and compliance with local and international standards (e.g., GMP, ISO)
• Proven track record in manufacturing pharmaceutical liquids or tablets (depending on dosage form)
• Capability to scale production based on demand forecasts
• Robust quality control and quality assurance procedures

Distribution Channels and Regional Suppliers

Authorized Distributors

The distribution network for KITABIS PAK involves authorized pharmaceutical distributors, mandated to uphold quality and integrity during storage and transportation.

• Domestic Distributors: Authorized by the original manufacturer or license holder to supply within Pakistan.
• Regional Distributors: For markets outside Pakistan, licensed regional distributors facilitate importation, storage, and local marketing, subject to regional regulatory approvals.

Importation and International Suppliers

In markets where KITABIS PAK is not produced locally, importation relies on established international suppliers who procure the drug from licensed manufacturers. These suppliers must adhere to import regulations, customs, and pharmaceutical import licensing.

Regulatory and Compliance Considerations

Suppliers must comply with regulatory standards such as the Drugs Act of Pakistan, FDA regulations in the US, EMA standards in Europe, or respective regional bodies. These standards ensure that the distribution chain maintains product integrity and avoids counterfeit or substandard entries into the supply chain.

• GMP Certification: Mandatory for manufacturing entities.
• Import Licenses: Necessary for international supply chains.
• Product Registration: Distributors must hold valid registration certificates for legal distribution.

Market Dynamics and Supply Chain Challenges

The supply of KITABIS PAK is influenced by various factors, including manufacturing capacity constraints, regulatory changes, and geopolitical issues.

• Supply Chain Disruptions: Global logistical challenges and regulatory delays can impact the availability of KITABIS PAK.
• Regulatory Approvals: Variations in regional approval processes can affect the entry of new suppliers.
• Pricing and Competition: Market competition among manufacturers and distributors influences pricing strategies, impacting supplier selection.

Emerging Suppliers and Future Outlook

Emerging suppliers, particularly those employing innovative manufacturing techniques or offering competitive pricing, are likely to enter the KITABIS PAK supply chain, especially with expanding markets or new indications. Strategic partnerships with local manufacturers and international CMOs can enhance supply stability and quality assurance.

Conclusion

A robust and compliant supply network is critical to ensuring consistent access to KITABIS PAK. Leading pharmaceutical manufacturers—both domestic and international—serve as primary suppliers, supported by authorized distributors and regulatory frameworks. Continuous monitoring of market dynamics and adherence to quality standards are essential for stakeholders seeking reliable sourcing options.

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Key Takeaways

• Authorized Manufacturers Are Key: Only licensed, GMP-compliant factories should be considered for sourcing KITABIS PAK.
• Regulatory Compliance Is Paramount: Ensure suppliers hold necessary licenses and certifications for legal and quality assurance.
• Global and Local Distributors Play Vital Roles: Established distribution channels underpin reliable delivery and product integrity.
• Supply Chain Risks Require Management: Be vigilant about potential disruptions due to logistical or regulatory issues.
• Emerging Suppliers Offer Opportunities: Strategic partnerships with innovative manufacturers can improve supply stability and cost efficiency.

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FAQs

1. Who are the main manufacturing companies for KITABIS PAK?
Several licensed pharmaceutical manufacturers operate within Pakistan, and some international CMOs produce KITABIS PAK under licensing agreements. Exact names depend on regional licensing and proprietary agreements.

2. How can I verify if a supplier is authorized to distribute KITABIS PAK?
Verify licensing and certification through regulatory agencies such as the Drug Regulatory Authority (DRA) of Pakistan or relevant regional authorities. Confirm product registration numbers and GMP compliance certificates.

3. Are there international suppliers for KITABIS PAK?
Yes, some international distributors import KITABIS PAK, depending on regional market approvals and licensing agreements. These entities must adhere to regional import and quality standards.

4. What challenges might affect the supply chain of KITABIS PAK?
Potential disruptions include manufacturing capacity limitations, regulatory delays, geopolitical issues, logistical challenges, and compliance requirements.

5. How does regulatory compliance impact supplier selection?
Strict regulatory standards ensure product safety and efficacy. Suppliers must maintain certifications like GMP and obtain necessary licensing to prevent legal and quality issues.

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References

1. Drug Regulatory Authority of Pakistan (DRAP). Licensing and Registration Regulations.
2. World Health Organization. Good Manufacturing Practices (GMP) Guidelines.
3. Pakistan Pharmaceutical Industry Reports. Market Trends and Regulatory Updates.
4. International Pharmaceutical Regulators Forum. Supply Chain Standards.
5. Industry analysis reports on pharmaceutical manufacturing and distribution.