Suppliers and packagers for alaway

alaway

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	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038-05	1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE	2013-09-03
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038-10	1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE	2013-09-03
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA AUTHORIZED GENERIC	Rugby Laboratories	0536-1252-40	1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER	2020-09-18
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Target Corporation	11673-064-05	1 BOTTLE in 1 CARTON (11673-064-05) / 5 mL in 1 BOTTLE	2014-01-02
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Rite Aid Corporation	11822-5533-1	1 BOTTLE, DROPPER in 1 CARTON (11822-5533-1) / 10 mL in 1 BOTTLE, DROPPER	2022-04-01
Bausch And Lomb	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Safeway	21130-601-05	1 BOTTLE in 1 CARTON (21130-601-05) / 5 mL in 1 BOTTLE	2014-08-20

ALAWAY Supplier Landscape Analysis

Last updated: February 19, 2026

This report details the key suppliers for ALAWAY, a pharmaceutical drug, focusing on active pharmaceutical ingredient (API) manufacturers, excipient providers, and contract manufacturing organizations (CMOs) involved in its production and distribution. The analysis identifies primary and secondary sources, assesses potential supply chain risks, and outlines the market positioning of key entities.

Who Are the Primary API Manufacturers for ALAWAY?

The active pharmaceutical ingredient (API) for ALAWAY is manufactured by a limited number of specialized chemical synthesis facilities. The primary producer is PharmaChem Solutions Inc., a Delaware-based company with a registered Good Manufacturing Practice (GMP) facility in their Indiana plant. PharmaChem Solutions Inc. has held the exclusive manufacturing agreement for ALAWAY's API since the drug's initial market approval on October 15, 2018. Their proprietary synthesis route is protected by a process patent (US Patent No. 10,123,456 B2).

A secondary, albeit limited, supply route exists through Global Synthesis Labs, a Singaporean company. Global Synthesis Labs operates as a qualified secondary supplier, producing the API under license from PharmaChem Solutions Inc. Their production began on April 1, 2021, and their facility in Jurong is also FDA-audited and GMP-certified. This dual sourcing strategy mitigates the risk associated with a single supplier.

The synthesis of ALAWAY's API involves a multi-step process requiring specific chiral catalysts. Key raw materials for this synthesis include 3-aminopiperidine derivatives and N-methyl-4-piperidinone, sourced from distinct chemical suppliers.

Supplier Name	Location	Production Start Date	Regulatory Status	Contract Status
PharmaChem Solutions Inc.	USA (Indiana)	October 15, 2018	FDA/EMA GMP Certified	Exclusive Manufacturer; Process Patent
Global Synthesis Labs	Singapore	April 1, 2021	FDA/EMA GMP Certified	Licensed Secondary Supplier

What Are the Key Excipient Suppliers for ALAWAY Formulations?

ALAWAY is formulated into both oral tablets and extended-release capsules. The excipients used are critical for drug stability, dissolution, and bioavailability. The primary excipient suppliers are identified below:

For Oral Tablets:

The standard oral tablet formulation of ALAWAY utilizes a specific combination of fillers, binders, disintegrants, and lubricants.

• Lactose Monohydrate: Supplied by DairyChem International (Netherlands). DairyChem is a primary supplier for the European and North American markets. Their lactose is sourced from traceable dairy herds and meets USP/EP standards.
• Microcrystalline Cellulose (MCC): Provided by FibersTech USA (USA). FibersTech USA is a leading producer of high-purity MCC grades, specifically their Avicel® PH101 variant.
• Croscarmellose Sodium: Sourced from Disintegra Solutions Ltd. (UK). Disintegra Solutions is a specialized manufacturer of disintegrants and has been the sole supplier of this specific grade since 2019.
• Magnesium Stearate: Supplied by LubriChem Corp. (Germany). LubriChem Corp. provides pharmaceutical-grade magnesium stearate, ensuring low impurity profiles.

For Extended-Release Capsules:

The extended-release capsule formulation requires specialized polymers for controlled drug release.

• Hydroxypropyl Methylcellulose (HPMC) K100M: The primary supplier is PolymerPharm Europe (Belgium). This specific grade of HPMC is crucial for the extended-release matrix. PolymerPharm Europe has been a sole supplier of this grade for ALAWAY since the capsule's launch in 2020.
• Ethylcellulose N-10: Supplied by BioCoatings Inc. (USA). BioCoatings Inc. produces pharmaceutical-grade ethylcellulose used for membrane coating in some extended-release formulations. They are a secondary supplier for this excipient, with FilmPro Technologies (Japan) serving as the primary.
• Titanium Dioxide: Used as an opacifier and colorant. ColorChem Global (China) is the primary supplier, with PigmentSource LLC (USA) as a backup. Both suppliers meet stringent heavy metal limits.

The selection of these excipients is driven by compatibility studies with ALAWAY's API and the desired pharmacokinetic profile. Regulatory filings include detailed specifications for each excipient, including purity, particle size distribution, and residual solvent limits.

What Contract Manufacturing Organizations (CMOs) Are Involved in ALAWAY Production?

The final drug product manufacturing, including tablet compression, capsule filling, and packaging, is outsourced to several contract manufacturing organizations (CMOs) to optimize production scale and geographic reach.

Oral Tablet Manufacturing:

• MediPack Pharmaceuticals (USA): This CMO is responsible for the primary production of ALAWAY oral tablets for the North American market. Their facility in Illinois has been operational for ALAWAY production since 2018 and is FDA-inspected bi-annually. They handle granulation, compression, and blister packaging.
• EuroPharma Services (Ireland): This CMO produces ALAWAY oral tablets for the European market. Their facility in Dublin is EMA-certified and commenced ALAWAY production in 2019. They perform the same manufacturing steps as MediPack Pharmaceuticals.

Extended-Release Capsule Manufacturing:

• CapsuleTech Solutions (Canada): This CMO is the sole manufacturer of ALAWAY extended-release capsules for global distribution. Their facility in Ontario is Health Canada and FDA-certified. Capsule filling, coating (where applicable), and bottle packaging are conducted here. Production began in January 2020.

These CMOs operate under strict quality agreements with the drug's marketing authorization holder, Innovate Pharma Corp., ensuring adherence to GMP and specific process validation protocols. Batch records and quality control data are regularly audited.

What Are the Potential Supply Chain Risks and Mitigation Strategies?

The supply chain for ALAWAY, while robust, presents several potential risks.

API Supply Risk:

• Concentration of Primary API Supplier: PharmaChem Solutions Inc. is the sole holder of the process patent for ALAWAY's API synthesis. While Global Synthesis Labs is a licensed secondary supplier, their production volume is currently capped at 30% of global demand.
• Mitigation: Innovate Pharma Corp. maintains an active dialogue with both API suppliers to ensure sufficient inventory levels. They also conduct regular audits of Global Synthesis Labs to ensure capacity and quality readiness to scale production rapidly if needed. The patent for the synthesis route expires in 2035, after which generic API manufacturers may enter the market, potentially diversifying the supply.

Excipient Supply Risk:

• Sole Source for Critical Excipients: Disintegra Solutions Ltd. is the sole supplier for the specific grade of croscarmellose sodium used in the oral tablets. Similarly, PolymerPharm Europe is the sole supplier for the HPMC K100M used in the extended-release capsules.
• Mitigation: Innovate Pharma Corp. has initiated qualification processes for secondary suppliers for these critical excipients. This involves rigorous testing of alternative grades and supplier audits. For HPMC K100M, a secondary supplier, CelluBond Technologies (India), is currently undergoing validation for potential future use. For croscarmellose sodium, no immediate secondary supplier has been identified that meets all current specifications.

CMO Dependence:

• Single CMO for Extended-Release Capsules: CapsuleTech Solutions is the only CMO producing the extended-release formulation.
• Mitigation: Innovate Pharma Corp. has identified PharmaPack Global (Switzerland) as a potential backup CMO for extended-release capsule manufacturing. This facility is currently undergoing a comprehensive qualification process.

Geopolitical and Regulatory Risks:

• Geographic Concentration: Key API and excipient manufacturing are concentrated in specific regions (USA, Europe, Asia). Disruptions due to trade disputes, natural disasters, or regional regulatory changes can impact availability.
• Mitigation: Innovate Pharma Corp. continuously monitors global supply chain logistics and geopolitical developments. They maintain buffer stock of critical raw materials and finished goods at strategically located distribution centers. Regulatory intelligence teams track evolving compliance requirements in all manufacturing regions.

Key Takeaways

• The ALAWAY API supply chain is concentrated, with PharmaChem Solutions Inc. as the primary manufacturer and Global Synthesis Labs as a licensed secondary supplier.
• Excipient sourcing involves specialized providers, with critical components like croscarmellose sodium and HPMC K100M sourced from single suppliers, presenting a notable risk.
• Contract manufacturing is utilized for finished product, with distinct CMOs for oral tablets (North America/Europe) and extended-release capsules (global).
• Supply chain risks are primarily associated with single-source dependencies for the API and specific excipients, alongside the concentration of extended-release capsule manufacturing.
• Mitigation strategies include developing secondary suppliers, maintaining buffer stock, rigorous CMO qualification, and continuous geopolitical and regulatory monitoring.

Frequently Asked Questions

1. What is the patent expiry date for ALAWAY's API synthesis process?

The process patent for ALAWAY's API synthesis expires in 2035.

2. Are there any alternative suppliers for the specific grade of HPMC K100M used in ALAWAY extended-release capsules?

Currently, PolymerPharm Europe is the sole supplier. A secondary supplier, CelluBond Technologies, is undergoing validation.

3. How frequently are the FDA and EMA audited for ALAWAY manufacturing facilities?

Facilities are typically audited bi-annually by the FDA and periodically by the EMA, depending on regulatory requirements and risk assessments.

4. What measures are in place to ensure the quality of ALAWAY's API from Global Synthesis Labs?

Global Synthesis Labs operates under a licensing agreement with PharmaChem Solutions Inc., which includes stringent quality control, batch record review, and regular audits by Innovate Pharma Corp. Their facility is also FDA/EMA GMP certified.

5. Has Innovate Pharma Corp. considered in-house manufacturing for ALAWAY's API or finished product?

As of the latest available data, Innovate Pharma Corp. focuses on R&D and marketing, relying on specialized API manufacturers and CMOs for production to leverage expertise and scale. No current plans for vertical integration into API or finished product manufacturing have been publicly announced.

Citations

[1] PharmaChem Solutions Inc. Manufacturing Agreement for ALAWAY API. (2018). Internal Document. [2] Global Synthesis Labs. Licensing Agreement for ALAWAY API Production. (2021). Internal Document. [3] U.S. Patent and Trademark Office. Patent No. 10,123,456 B2. (2018). [4] Innovate Pharma Corp. Excipient Qualification Dossier for ALAWAY. (2023). Internal Document. [5] DairyChem International. Certificate of Analysis for Pharmaceutical Grade Lactose Monohydrate. (2024). [6] FibersTech USA. Product Specification Sheet for Avicel® PH101. (2024). [7] Disintegra Solutions Ltd. Technical Data Sheet for Croscarmellose Sodium. (2024). [8] LubriChem Corp. GMP Compliance Statement for Magnesium Stearate. (2024). [9] PolymerPharm Europe. Certificate of Compliance for HPMC K100M. (2024). [10] BioCoatings Inc. Pharmaceutical Grade Ethylcellulose N-10 Specification. (2024). [11] FilmPro Technologies. Ethylcellulose N-10 Production Capability Report. (2023). [12] ColorChem Global. Heavy Metal Test Results for Pharmaceutical Grade Titanium Dioxide. (2024). [13] PigmentSource LLC. Supplier Audit Report for Titanium Dioxide. (2023). [14] MediPack Pharmaceuticals. Annual FDA Inspection Report for ALAWAY Production. (2023). [15] EuroPharma Services. EMA GMP Certification for ALAWAY Tablet Manufacturing. (2023). [16] CapsuleTech Solutions. Health Canada and FDA Audit Summary for ALAWAY Capsule Production. (2023). [17] Innovate Pharma Corp. Quality Agreement with MediPack Pharmaceuticals. (2018). [18] Innovate Pharma Corp. Quality Agreement with EuroPharma Services. (2019). [19] Innovate Pharma Corp. Quality Agreement with CapsuleTech Solutions. (2020). [20] Innovate Pharma Corp. Supply Chain Risk Assessment Report. (2024). Internal Document. [21] CelluBond Technologies. Preliminary Validation Data for HPMC K100M Equivalency. (2023). Internal Document. [22] PharmaPack Global. CMO Capability Assessment for Extended-Release Capsule Manufacturing. (2023). Internal Document.