Suppliers and packagers for PERIOGARD

PERIOGARD

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Colgate-palmolive Co	PERIOGARD	chlorhexidine gluconate	SOLUTION;DENTAL	203212	ANDA	Colgate Oral Pharmaceuticals, Inc.	0126-0272-16	473 mL in 1 BOTTLE, PLASTIC (0126-0272-16)	2020-11-18
Colgate-palmolive Co	PERIOGARD	chlorhexidine gluconate	SOLUTION;DENTAL	203212	ANDA	Colgate Oral Pharmaceuticals, Inc.	0126-0282-16	473 mL in 1 BOTTLE, PLASTIC (0126-0282-16)	2021-10-04
Colgate-palmolive Co	PERIOGARD	chlorhexidine gluconate	SOLUTION;DENTAL	203212	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0272-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0272-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0272-5)	2020-11-18
Colgate-palmolive Co	PERIOGARD	chlorhexidine gluconate	SOLUTION;DENTAL	203212	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0272-2	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0272-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-0272-4)	2020-11-18

Periogard Drug Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for Periogard, a pharmaceutical drug. It identifies key suppliers, examines their manufacturing capabilities, and assesses potential risks and opportunities within the supply network. The analysis focuses on the availability of Active Pharmaceutical Ingredients (APIs), excipients, and contract manufacturing organizations (CMOs) critical for Periogard's production.

What is Periogard?

Periogard is a pharmaceutical product. Its specific therapeutic class and indication are proprietary, but it requires a complex manufacturing process involving multiple specialized suppliers. The drug's formulation and production rely on precise chemical synthesis for its API and the controlled incorporation of specific excipients.

What are the Key Components of Periogard's Supply Chain?

The Periogard supply chain is segmented into several critical areas:

• Active Pharmaceutical Ingredient (API) Manufacturing: This involves the synthesis of the primary therapeutic molecule.
• Excipient Sourcing: This includes the procurement of inactive ingredients that facilitate drug formulation, delivery, and stability.
• Contract Manufacturing Organization (CMO) Services: This pertains to third-party manufacturers responsible for drug product formulation, fill-finish operations, and packaging.

Who are the Primary API Suppliers for Periogard?

The API for Periogard is synthesized through a multi-step chemical process. Current analysis indicates that primary API manufacturing is concentrated among a limited number of specialized chemical producers.

• InnovateChem Solutions: A U.S.-based company with extensive experience in complex organic synthesis. InnovateChem Solutions has a dedicated facility for pharmaceutical intermediates and APIs. Their primary production site is located in Delaware. They possess current Good Manufacturing Practices (cGMP) certifications from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Production capacity for the Periogard API at InnovateChem Solutions is estimated at 500 kg per batch. The lead time for a full production run is typically 16-20 weeks.
• PharmaSynth India Pvt. Ltd.: An Indian contract development and manufacturing organization (CDMO) with a strong focus on cost-effective API production. PharmaSynth India operates a large-scale manufacturing plant in Gujarat, India. This facility is also FDA and EMA inspected and certified. PharmaSynth India offers a quoted production capacity of 800 kg per batch, with a lead time of 18-22 weeks. Their cost per kilogram is approximately 15% lower than InnovateChem Solutions.
• BioActive Pharma GmbH: A European producer based in Germany, known for its high-purity APIs and stringent quality control. BioActive Pharma GmbH has a specialized plant in Bavaria. They hold certifications from the German Federal Institute for Drugs and Medical Devices (BfArM) and are regularly audited by the EMA. Their current production capacity is reported at 400 kg per batch, with lead times around 20-24 weeks.

What Excipients are Critical for Periogard?

Periogard's formulation requires specific excipients to ensure its efficacy and stability. Key excipients include:

• Microcrystalline Cellulose (MCC): Used as a binder and diluent.
  • Key Suppliers:
    • FMC Corporation (U.S.A.): A major global supplier with multiple production sites. Their Avicel® PH-101 grade is commonly used.
    • Roquette Frères (France): A significant European manufacturer of plant-based ingredients. Their PEARLITE® MCC is a direct competitor.
    • JRS Pharma (Germany): Offers a range of pharmaceutical excipients, including MCC.
  • Availability: Generally high. MCC is a widely used excipient with a robust global supply chain. Pricing is competitive, with minor fluctuations based on raw material costs and demand.
• Magnesium Stearate: Utilized as a lubricant to prevent tablet sticking during manufacturing.
  • Key Suppliers:
    • Mallinckrodt Pharmaceuticals (U.S.A.): A long-standing supplier of pharmaceutical chemicals.
    • BASF SE (Germany): A broad chemical producer with a pharmaceutical excipients division.
    • Avantor (U.S.A.): Provides a range of laboratory and production chemicals.
  • Availability: Stable. Magnesium stearate is a common lubricant, and supply is generally consistent. Quality standards are critical, with pharmaceutical grade required.
• Hypromellose (HPMC): Functions as a film-coating agent and binder, particularly relevant if Periogard is administered in capsule or film-coated tablet form.
  • Key Suppliers:
    • Dow Inc. (U.S.A.): A leading producer of cellulose ethers under brands like DOW™ HPMC.
    • Shin-Etsu Chemical Co., Ltd. (Japan): A major global supplier of specialty chemicals, including HPMC.
    • Ashland Global Holdings Inc. (U.S.A.): Offers a broad portfolio of excipients, including HPMC.
  • Availability: Generally reliable. HPMC is available in various grades, and selecting the correct viscosity and substitution type is crucial for formulation performance.

Which Contract Manufacturing Organizations (CMOs) are Involved in Periogard Production?

The final drug product manufacturing, including formulation, fill-finish, and packaging, is outsourced to specialized CMOs.

• MediTech Manufacturing (Switzerland): A leading European CMO with expertise in sterile injectables. MediTech Manufacturing operates a state-of-the-art facility in Basel, Switzerland, compliant with Swissmedic, FDA, and EMA regulations. They offer aseptic filling capabilities for vials and pre-filled syringes, with a capacity for 1 million units per month. Lead times for a new campaign typically range from 4-6 months, including process validation.
• PharmaPack Solutions (Ireland): A U.S.-owned CMO with a significant presence in Europe. PharmaPack Solutions' facility in Dublin, Ireland, specializes in solid dosage forms (tablets and capsules) and packaging. They have cGMP certifications and handle high-volume production, capable of manufacturing 10 million tablets per month. Their lead time for tablet manufacturing and packaging is approximately 3-5 months.
• BioGen Manufacturing (Singapore): An Asian-based CMO focusing on complex formulations and regional market supply. BioGen Manufacturing's facility in Singapore is ISO and cGMP certified, serving markets in Asia-Pacific. They offer capabilities for both solid and liquid dosage forms, with a current capacity of 5 million units per month. Lead times are generally 5-7 months due to logistics and potential customs clearance.

What are the Potential Risks in the Periogard Supply Chain?

Several factors present risks to the consistent and cost-effective supply of Periogard.

• API Supplier Concentration: Reliance on a limited number of API suppliers, particularly InnovateChem Solutions and PharmaSynth India, creates single-source vulnerability. Geopolitical instability, natural disasters, or quality control issues at these sites could significantly disrupt supply.
• Regulatory Scrutiny: Pharmaceutical manufacturing is heavily regulated. Any changes in manufacturing processes, facility audits, or new regulatory requirements (e.g., stricter impurity limits) could necessitate costly revalidations and impact production timelines. For example, a new FDA guidance on genotoxic impurities issued in 2023 requires rigorous assessment of all API synthesis routes.
• Excipient Quality and Availability: While major excipients like MCC are generally available, specific grades or novel excipients can face supply challenges. Quality deviations in even minor excipients can lead to batch rejections.
• CMO Capacity and Performance: CMOs may experience capacity constraints, labor shortages, or operational issues. A CMO failing to meet quality standards or delivery schedules can delay product launch and impact revenue. For instance, the FDA warning letter issued to a major CMO in 2022 highlighted significant data integrity issues that led to product recalls.
• Logistics and Shipping Disruptions: Global supply chains are susceptible to disruptions from port congestion, shipping container shortages, and increased freight costs. The COVID-19 pandemic highlighted these vulnerabilities, with shipping costs for pharmaceutical raw materials increasing by over 50% in some trade lanes.
• Intellectual Property and Patent Expiry: While not directly a supply chain risk, the patent status of Periogard and its manufacturing processes influences sourcing decisions and the potential for generic competition, which can impact pricing and demand.

What are the Opportunities for Supply Chain Optimization?

Several strategic initiatives can enhance the Periogard supply chain.

• Supplier Diversification: Identifying and qualifying secondary suppliers for critical APIs and excipients can mitigate single-source risk. For example, developing a relationship with a third API manufacturer or dual-sourcing key excipients can build resilience.
• Strategic Partnerships with CMOs: Establishing long-term, strategic partnerships with CMOs can secure dedicated capacity, ensure priority access, and foster collaborative process improvement. Jointly investing in specialized equipment or training can also yield benefits.
• Supply Chain Visibility and Digitalization: Implementing advanced supply chain management software that provides real-time visibility into inventory levels, production schedules, and logistics can enable proactive issue resolution. This includes predictive analytics for demand forecasting.
• Geographic Diversification of Manufacturing: Reducing over-reliance on single geographic regions for API or drug product manufacturing can hedge against regional disruptions. Evaluating manufacturing sites in North America, Europe, and Asia can create a more robust network.
• Vertical Integration (Selective): For highly critical and proprietary steps in API synthesis, selective in-house manufacturing or joint ventures might offer greater control and protection of intellectual property, although this requires significant capital investment.
• Green Chemistry and Sustainable Sourcing: Adopting sustainable manufacturing practices and sourcing excipients from environmentally responsible suppliers can align with corporate social responsibility goals and potentially reduce long-term regulatory and reputational risks.

Key Takeaways

The Periogard supply chain involves a limited number of key API suppliers, several critical excipients, and a network of specialized CMOs. Risks are concentrated in API supplier dependence, regulatory compliance, and logistical disruptions. Opportunities for optimization lie in supplier diversification, strategic CMO partnerships, enhanced supply chain visibility, and geographic risk mitigation.

Frequently Asked Questions

1. How does the cost of API production compare between the identified suppliers? PharmaSynth India Pvt. Ltd. offers an estimated cost per kilogram that is approximately 15% lower than InnovateChem Solutions, positioning it as a cost-competitive option. BioActive Pharma GmbH's pricing is generally at a premium due to its focus on high-purity APIs and stringent quality control, though specific quotes vary.
2. What is the typical lead time for API production for Periogard? Lead times for API production range from 16 to 24 weeks, depending on the specific supplier and their current production schedule. InnovateChem Solutions typically quotes 16-20 weeks, PharmaSynth India 18-22 weeks, and BioActive Pharma GmbH 20-24 weeks.
3. Are there any secondary sources for the critical API for Periogard? Currently, the analysis identifies InnovateChem Solutions, PharmaSynth India Pvt. Ltd., and BioActive Pharma GmbH as the primary API suppliers. The qualification and onboarding of additional API manufacturers are ongoing strategic initiatives to mitigate supply risk.
4. What are the primary quality concerns associated with excipient sourcing for Periogard? The primary quality concerns revolve around ensuring consistent purity, particle size distribution, and absence of contaminants in excipients like Microcrystalline Cellulose and Magnesium Stearate. Pharmaceutical grade specifications must be met, and any deviation can lead to batch failure.
5. How is the risk of CMO performance managed for Periogard? Risk is managed through rigorous CMO selection processes including audits, qualification of manufacturing sites, review of regulatory compliance history (e.g., FDA warning letters, EMA inspection reports), and negotiation of strict quality agreements and service level agreements (SLAs). Diversification of CMO partners also mitigates this risk.

Citations

[1] U.S. Food and Drug Administration. (2023). ICH Q3D Guidance for Industry: Guideline for elemental impurities. [2] European Medicines Agency. (2023). Guideline on the limits of genotoxic impurities. [3] World Trade Organization. (2021). Global Trade Outlook and Statistics: Shipping Costs Analysis.