Suppliers and packagers for NICOTROL

NICOTROL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714	NDA	Pharmacia & Upjohn Company LLC	0009-5400-01	28 TRAY in 1 CARTON (0009-5400-01) / 6 CARTRIDGE in 1 TRAY / 1 INHALANT in 1 CARTRIDGE	1997-05-02
Pfizer Inc	NICOTROL	nicotine	SPRAY, METERED;NASAL	020385	NDA	Pharmacia & Upjohn Company LLC	0009-5401-01	4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY	1996-05-22

Suppliers of the Pharmaceutical Drug Nicotrol

Nicotrol, a nicotine replacement therapy (NRT) product, is primarily available as a nasal spray (Nicotrol NS) and was previously offered as an inhaler (discontinued in 2023). This report details the suppliers and distribution networks for Nicotrol NS, focusing on manufacturers, distributors, and retail channels, alongside insights into nicotine active pharmaceutical ingredient (API) suppliers.

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Pfizer as the Manufacturer of Nicotrol NS

Pfizer Inc. is the sole manufacturer of Nicotrol NS (nicotine nasal spray), a prescription medication designed to aid smoking cessation. The nasal spray delivers 0.5 mg of nicotine per metered dose (1 mg per two sprays)[3][4][9][11]. Each 10 mL bottle contains 100 mg of nicotine in an isotonic aqueous solution with a pH of 7, formulated without chlorofluorocarbons[4][9]. The pharmacological profile of Nicotrol NS includes rapid absorption through the nasal mucosa, achieving peak plasma concentrations of 2–12 ng/mL within 4–15 minutes[4][9].

In May 2023, Pfizer announced the discontinuation of the Nicotrol Inhaler due to a resin shortage affecting mouthpiece production[13]. The nasal spray remains available, with dosing guidelines recommending 1–2 doses (1–2 mg) per hour, up to a maximum of 40 doses daily for three months[3][4].

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Authorized Distributors of Nicotrol NS

Pfizer relies on a network of licensed wholesalers and specialty distributors to supply Nicotrol NS to pharmacies and healthcare providers. Key distributors include:

Major Pharmaceutical Wholesalers

1. McKesson: A primary distributor listed in Pfizer’s U.S. wholesaler network, supplying Nicotrol NS under the product code 00009540101[14][16].
2. Cardinal Health: Authorized to distribute Pfizer’s full product line, including Nicotrol NS[16].
3. Owens & Minor: Operates distribution centers in multiple states, including Maryland and West Virginia, and is compliant with Pfizer’s Drug Supply Chain Security Act (DSCSA) requirements[16].
4. Medline Industries: Distributes Nicotrol NS through facilities in Alaska, Arkansas, and Maryland[16].

These wholesalers adhere to Pfizer’s stringent distribution policies, which mandate direct purchases from Pfizer or other authorized distributors during supply shortages[16].

Retail and Online Pharmacies

1. Amazon Pharmacy: Offers Nicotrol NS with free shipping for Prime members, allowing patients to transfer prescriptions directly[1].
2. DrugsDepot: A licensed pharmacy providing Nicotrol NS (NDC 00009-5401-01) through physician-authorized orders[17].
3. Axiom Medicals: Supplies Nicotrol NS in bulk (CT/4 boxes) via direct shipments from Pfizer[14].

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Nicotine API Suppliers Supporting Pharmaceutical Production

While Pfizer manufactures Nicotrol NS, the nicotine API is sourced from specialized producers. Notable suppliers include:

Global Nicotine Manufacturers

1. Contraf-Nicotex-Tobacco GmbH (CNT): A German company supplying high-purity nicotine to pharmaceutical and e-liquid industries, known for advanced extraction processes[2].
2. BGP Group: An India-based WHO-GMP-certified manufacturer producing nicotine polacrilex, nicotine salts, and nicotine resinate for NRT products[8][12].
3. Nicobrand: A UK-based supplier with over 30 years of experience in pharmaceutical-grade nicotine, including resins for inhalers[2][12].
4. Nico Orgo Marketing Pvt. Ltd.: Produces USP/EP-grade nicotine in ISO 6-certified facilities, serving Indian and international markets[15].

These companies ensure compliance with international standards (e.g., USP, EP) and provide customized nicotine formulations for NRT products[2][8][15].

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Regulatory and Supply Chain Considerations

Discontinuation of Nicotrol Inhaler

Pfizer ceased production of the Nicotrol Inhaler in September 2023 due to a resin shortage, unrelated to safety concerns[13]. Patients transitioning from the inhaler are advised to consult healthcare providers for alternative therapies, such as nicotine patches or lozenges.

Distribution Compliance

Pfizer mandates that distributors maintain valid licenses and DSCSA compliance to prevent counterfeit products[16]. Audits and traceability protocols are enforced to ensure supply chain integrity.

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Key Takeaways

• Manufacturer: Pfizer exclusively produces Nicotrol NS.
• Distributors: Major wholesalers (McKesson, Cardinal Health) and pharmacies (Amazon, DrugsDepot) supply the nasal spray.
• API Suppliers: CNT, BGP Group, and Nicobrand provide nicotine for pharmaceutical use.
• Discontinued Product: Nicotrol Inhaler was phased out in 2023 due to component shortages.

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FAQs

1. Can Nicotrol NS be purchased without a prescription?
   No, Nicotrol NS requires a valid prescription[1][17].

2. What is the maximum daily dose of Nicotrol NS?
   Up to 40 doses (80 sprays) daily for three months[4][9].

3. Which companies supply nicotine for Nicotrol NS?
   BGP Group and CNT are key API suppliers[2][8][15].

4. Is the Nicotrol Inhaler still available?
   No, Pfizer discontinued it in 2023[13].

5. Where can patients find Nicotrol NS online?
   Amazon Pharmacy and DrugsDepot offer prescription transfers[1][17].

References

1. https://pharmacy.amazon.com/Nicotrol-Brand-Nicotine-Metered-Nasal/dp/B084BQF9C9
2. https://www.nicovaper.com/blog/top-nicotine-manufacturers-in-the-world
3. https://www.empr.com/drug/nicotrol-ns/
4. https://www.drugs.com/pro/nicotrol-ns.html
5. https://www.tobaccotactics.org/article/tobacco-company-investments-in-pharmaceutical-nrt-products/
6. https://www.goodrx.com/nicotine/what-is
7. https://www.drugs.com/cdi/nicotrol.html
8. https://www.bgpgroup.biz
9. https://cdn.pfizer.com/pfizercom/products/uspi_nicotrol.pdf
10. https://mms.mckesson.com/product/642274/Pfizer-Pharmaceuticals-Brand-00009540001
11. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020385s011lbl.pdf
12. https://pharmaoffer.com/api-excipient-supplier/drugs-for-nicotine-addiction/nicotine
13. https://cdn.pfizer.com/pfizercom/DHCP_Letter_Nicotrol_Inhaler_5.30.2023.pdf
14. https://axiommedicals.com/products/pfizer-stop-smoking-aid-nicotrol-r-ns-10-mg-strength-nasal-spray-m-655232-1670-ct-4
15. https://www.nicovaper.com/about
16. https://www.pfizer.com/products/distributors/state
17. https://www.drugsdepot.com/store.php/drugsdepot/pd9620273/nicotrol-ns-10-mg-nasal-spray-4x10-ml-by-pfizer-pharma