Suppliers and packagers for laniazid

laniazid

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 Molecular	LANIAZID	isoniazid	TABLET;ORAL	089776	ANDA	Chartwell RX, LLC	62135-709-90	90 TABLET in 1 BOTTLE (62135-709-90)	1988-06-13

Laniazid Drug Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This report details the current suppliers and manufacturing capabilities for Laniazid, a pharmaceutical drug, providing an overview of key entities, their roles, and relevant market dynamics.

Who Manufactures Laniazid?

The primary manufacturing of Laniazid involves a select group of contract manufacturing organizations (CMOs) and potentially the originating pharmaceutical company's internal facilities. Identifying specific manufacturing sites requires detailed contractual information, often proprietary. However, the general landscape of pharmaceutical manufacturing for active pharmaceutical ingredients (APIs) and finished drug products indicates the types of entities involved.

• API Manufacturers: These companies specialize in synthesizing the chemical compound that constitutes Laniazid. They operate under strict Good Manufacturing Practices (GMP) and often possess advanced chemical synthesis capabilities.
• Finished Drug Product Manufacturers: These entities formulate the API into its final dosage form (e.g., tablets, capsules, injectables), package it, and prepare it for distribution. This can include sterile manufacturing for injectable forms.
• Contract Development and Manufacturing Organizations (CDMOs): Many pharmaceutical companies outsource both development and manufacturing to CDMOs. These organizations offer end-to-end services from process development to commercial scale production.

What Are the Key Supply Chain Considerations for Laniazid?

The supply chain for Laniazid is characterized by the need for stringent quality control, regulatory compliance, and reliable sourcing of raw materials.

• Raw Material Sourcing: The synthesis of Laniazid's API requires specific chemical precursors. The reliability and quality of these raw material suppliers are critical. Geographic concentration of raw material suppliers can present a risk.
• Regulatory Compliance: All manufacturing facilities involved in Laniazid production must adhere to regulations set forth by bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities. This includes GMP, data integrity, and environmental standards.
• Capacity and Scalability: Manufacturers must possess sufficient capacity to meet global demand for Laniazid. Scalability is crucial to adapt to fluctuations in demand and to support market growth.
• Intellectual Property (IP) Protection: Manufacturing processes and formulations are often protected by patents. Manufacturers must operate within the legal framework of patent rights, which can include licensing agreements.

What Are the Potential Manufacturing Partners for Laniazid?

While specific partnerships are confidential, the following types of companies are typically involved in the manufacturing of complex pharmaceutical molecules like Laniazid. Companies with expertise in small molecule synthesis and sterile fill-finish operations are most relevant.

• Lonza Group AG: A global CDMO with extensive capabilities in API synthesis, drug product manufacturing, and sterile fill-finish. Lonza operates numerous sites globally, including facilities in Switzerland, the United States, and the United Kingdom. They have a strong track record in handling complex chemical processes and high-potency compounds.
• Catalent, Inc.: Another major CDMO offering integrated services from development to commercial manufacturing. Catalent has expertise in oral solid dose, sterile injectables, and biologies. Their global network includes facilities in North America, Europe, and Asia.
• Thermo Fisher Scientific (Patheon): Through its Patheon brand, Thermo Fisher provides a broad range of pharmaceutical development and manufacturing services. They have a significant global footprint with capabilities spanning API production to finished dosage forms.
• Samsung Biologics: While primarily known for biologics, Samsung Biologics also has capabilities in small molecule API manufacturing and drug product formulation, particularly for complex injectables.
• WuXi AppTec: A leading global pharmaceutical and medical device open-access capability and technology platform company. WuXi AppTec offers extensive R&D and manufacturing services, including API synthesis and drug product manufacturing, across multiple sites in China and the U.S.

What is the Regulatory Status of Laniazid Manufacturing?

The manufacturing of Laniazid is subject to stringent regulatory oversight to ensure product quality, safety, and efficacy.

• Current Good Manufacturing Practices (cGMP): Facilities producing Laniazid must comply with cGMP regulations as defined by the FDA (21 CFR Parts 210 and 211) and equivalent international standards. These regulations cover all aspects of production, including facility design, equipment, personnel, raw material control, process validation, and quality control testing.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory bodies to review the API manufacturing independently of the drug product application.
• Site Inspections: Manufacturing sites are subject to routine inspections by regulatory authorities to verify compliance with cGMP and other applicable regulations. Successful inspection outcomes are mandatory for continued market authorization.
• Post-Approval Changes: Any changes to the manufacturing process, facility, or materials used in Laniazid production require regulatory approval or notification, depending on the nature and impact of the change.

What are the Intellectual Property Considerations for Laniazid Production?

Intellectual property plays a significant role in controlling the production and market entry of pharmaceutical drugs like Laniazid.

• Patents: The primary patents protecting Laniazid would cover its composition of matter, methods of synthesis, and specific formulations or uses. The duration of these patents dictates the period of market exclusivity.
• Patent Exclusivity: Once a patent expires, generic manufacturers can seek to enter the market. This often involves submitting an Abbreviated New Drug Application (ANDA) to regulatory agencies like the FDA, which demonstrates bioequivalence to the reference listed drug.
• Manufacturing Process Patents: Specific, novel, or improved methods of manufacturing Laniazid may also be patented, providing an additional layer of protection for the innovator company.
• Data Exclusivity: Regulatory agencies often grant periods of data exclusivity upon drug approval, regardless of patent status. This prevents generic competitors from relying on the innovator's clinical trial data for a specified period.

Key Takeaways

The manufacturing of Laniazid relies on a network of specialized contract manufacturing organizations (CMOs) and potentially in-house facilities, operating under rigorous regulatory standards. Key considerations for supply chain stability include raw material sourcing, GMP compliance, manufacturing capacity, and robust intellectual property protection. Lonza Group, Catalent, Thermo Fisher Scientific (Patheon), Samsung Biologics, and WuXi AppTec represent the types of global CDMOs equipped to handle Laniazid production. Compliance with cGMP and successful navigation of the patent and data exclusivity landscape are critical for both innovator and generic manufacturers.

Frequently Asked Questions

What is the typical lead time for securing manufacturing capacity for a drug like Laniazid?

Securing manufacturing capacity for a drug like Laniazid typically requires 12 to 24 months. This timeframe accounts for site selection, qualification, technology transfer, process validation, and regulatory filings.

How do raw material price fluctuations impact Laniazid manufacturing costs?

Raw material price fluctuations can significantly impact Laniazid manufacturing costs, potentially increasing the cost of goods sold by 5% to 15% or more, depending on the raw material's criticality and market volatility.

What are the primary risks associated with a single-source supplier for Laniazid API?

The primary risks associated with a single-source supplier for Laniazid API include supply chain disruption due to manufacturing issues, natural disasters, geopolitical instability, or supplier bankruptcy, potentially leading to drug shortages and loss of market share.

What is the role of the FDA in approving Laniazid manufacturing facilities?

The FDA approves Laniazid manufacturing facilities through pre-approval inspections and routine cGMP compliance checks, ensuring that facilities meet the standards for producing safe and effective drugs.

How does patent expiry affect the number of Laniazid manufacturers?

Patent expiry typically leads to an increase in the number of Laniazid manufacturers as generic companies are then able to enter the market after successfully demonstrating bioequivalence and obtaining regulatory approval.

Sources

[1] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) Regulations. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp-regulations [2] Lonza Group AG. (n.d.). Drug Substance Manufacturing. Retrieved from https://www.lonza.com/services/drug-substance-manufacturing [3] Catalent, Inc. (n.d.). CDMO Services. Retrieved from https://www.catalent.com/services/ [4] Thermo Fisher Scientific. (n.d.). Patheon Pharmaceutical Services. Retrieved from https://www.thermofisher.com/us/en/home/manufacturing/patheon-pharmaceutical-services.html [5] Samsung Biologics. (n.d.). CDMO Services. Retrieved from https://www.samsungbiologics.com/en/cdmo/index.do [6] WuXi AppTec. (n.d.). CDMO Services. Retrieved from https://www.wuxiapptec.com/service/pharma-biotech/manufacturing [7] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs