Suppliers and packagers for generic pharmaceutical drug: POSACONAZOLE

POSACONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	NOXAFIL POWDERMIX KIT	posaconazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	214770	NDA	Merck Sharp & Dohme LLC	0085-2224-02	8 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01)	2021-06-08
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596	NDA	Merck Sharp & Dohme LLC	0085-4331-01	1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS	2014-03-13
Aspiro	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	219057	ANDA	Camber Pharmaceuticals, Inc.	31722-370-31	1 VIAL, GLASS in 1 CARTON (31722-370-31) / 16.7 mL in 1 VIAL, GLASS	2024-12-23
Eugia Pharma	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	214842	ANDA	Eugia US LLC	55150-388-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSE	2023-12-26
Fresenius Kabi Usa	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	209983	ANDA	Fresensius Kabi USA, LLC	63323-685-17	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE	2023-12-26
Gland	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	217553	ANDA	Gland Pharma Limited	68083-577-01	1 VIAL in 1 CARTON (68083-577-01) / 16.7 mL in 1 VIAL	2023-12-26
Gland	POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	217553	ANDA	GLENMARK PHARMACEUTICALS INC., USA	68462-904-01	1 VIAL in 1 CARTON (68462-904-01) / 16.7 mL in 1 VIAL	2023-12-27

Suppliers for the Pharmaceutical Drug: Posaconazole

Last updated: February 20, 2026

Who are the primary manufacturers and suppliers of posaconazole?

Posaconazole, marketed primarily under the brand name Noxafil, is an antifungal medication used for prophylaxis and treatment of invasive fungal infections. It is marketed by several pharmaceutical companies, either directly or through authorized licensees.

Major Suppliers and Manufacturers

Company	Type	Marketed Brand(s)	Manufacturing Locations	Notable Details
Merck & Co. (MSD)	Proprietary, global leader	Noxafil	United States, manufacturing sites globally	Pioneered the drug's development, holds key patents.
Pfizer (formerly Schering-Plough)	Former producer, now Merck licensee	Noxafil, related formulations	Global manufacturing facilities	Previously commercialized, transitioned to Merck licensing.
Dr. Reddy’s Laboratories	Third-party manufacturer, generic	Posaconazole generics	India, other countries	Produces generic versions, often for markets outside US and EU.
Cipla	Generic manufacturer	Posaconazole generics	India	Supplies formulations for emerging markets.
Sun Pharmaceutical Industries	Generic manufacturer	Posaconazole generics	India, globally	Supplies US and international markets in generic form.

Supply Chain Sources and Distribution

• Authorized Generics: Companies like Dr. Reddy’s and Cipla produce generic versions mainly for markets outside the US or after patent expiry.
• Active Pharmaceutical Ingredient (API): Most suppliers source the API from specialized chemical producers or manufacture it in-house at large-scale facilities.
• Finished Dosage Forms: The finished drug is assembled, packaged, and distributed globally through licensed distribution networks, primarily managed by the brand owner—Merck & Co.

Patent and Licensing Considerations

• Merck’s patent protections for Noxafil, filed in multiple jurisdictions, typically expire in the early to mid-2020s, leading to increased generic market entries.
• A wave of generics is expected to flood markets post-patent expiration, with Indian manufacturers poised to occupy significant market share due to lower-cost manufacturing.

Regulatory Approvals and Market Presence

Region	Patent Status	Key Regulatory Body	Comments
United States	Patent expired (2016)	FDA	Generics available since late 2010s
European Union	Patent expired (2017)	EMA	Multiple generics approved
India	No patent barriers (2016)	CDSCO	Several generics marketed
Japan	Patent protection until 2024	PMDA	Upcoming generic entries expected

Market Trends and Future Supply Outlook

• The global antifungal market is projected to grow at a CAGR of approximately 5.3% from 2022-2028.
• Increased generic competition after patent expiry is expected to reduce prices and expand availability.
• Supply chain vulnerabilities could occur due to raw material shortages, manufacturing quality concerns, or geopolitical factors.

References

1. U.S. Food and Drug Administration (FDA). "Noxafil (Posaconazole)". (2022).
2. European Medicines Agency (EMA). "Market authorization for Posaconazole". (2022).
3. Indian pharmaceutical regulatory database. "Cipla and Dr. Reddy’s Posaconazole information". (2022).
4. Market research reports on antifungal drugs, 2022.