Suppliers and packagers for generic pharmaceutical drug: EPHEDRINE SULFATE

EPHEDRINE SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	CORPHEDRA	ephedrine sulfate	SOLUTION;INTRAVENOUS	208943	NDA	Endo USA, Inc.	42023-216-83	25 VIAL in 1 CARTON (42023-216-83) / 1 mL in 1 VIAL	2018-06-26
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289	NDA	Exela Pharma Sciences, LLC	51754-4200-4	25 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-04-15
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289	NDA	Exela Pharma Sciences, LLC	51754-4250-3	10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) / 5 mL in 1 SYRINGE, PLASTIC	2021-05-10

Ephedrine Sulfate: A Comprehensive Analysis of Global Suppliers and Market Dynamics

Ephedrine sulfate, a sympathomimetic amine primarily used to manage hypotension during anesthesia, has seen significant developments in its supply chain and regulatory landscape. This report synthesizes data from regulatory filings, patent expirations, manufacturing trends, and recent market entries to provide a detailed overview of the current state of ephedrine sulfate production and distribution. With major players like Malladi Drugs & Pharmaceuticals, Hikma Pharmaceuticals, and Nexus Pharmaceuticals expanding their portfolios, the market is characterized by both established generics and innovative ready-to-use formulations.

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Major Manufacturers of Ephedrine Sulfate

Leading Global Suppliers

The production of ephedrine sulfate is concentrated among a cohort of manufacturers with robust regulatory certifications. Malladi Drugs & Pharmaceuticals Limited (India) stands out as a dominant supplier, holding approvals from the USFDA, EDQM, ANSM, KFDA, and TGA[1][5]. Their expertise in adrenergic agonists positions them as a critical player in both active pharmaceutical ingredient (API) and finished-dose formulations. Pharm-RX Chemical (United States/India) and Avon Organics Limited (India) also feature prominently, with USDMF and CEP filings ensuring compliance in key markets[1][2].

European and North American manufacturers, including Siegfried AG (Switzerland) and Catalytica (United States), complement this network by focusing on high-purity APIs for injectable formulations[1]. The diversification of manufacturing bases—spanning India, China, and the United States—ensures resilience against regional supply chain disruptions[9].

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Regulatory Landscape and Quality Assurance

Good Manufacturing Practices (GMP) and DMF Filings

Ephedrine sulfate production is tightly regulated, with USDrug Master Files (USDMF) and CEPs (Certificates of Suitability) serving as benchmarks for quality. For instance, Spectrum Chemical’s USP-grade ephedrine sulfate is produced under cGMP conditions, adhering to 21 CFR Part 211 standards[6]. Similarly, Krebs Biochemicals & Industries Ltd (India) maintains WHO GMP certification, enabling exports to emerging markets[2][5].

The requirement for Certificates of Analysis (CoA) further underscores quality control. Suppliers like Embio Limited (India) provide batch-specific data aligning with USP, EP, and JP pharmacopeial standards, ensuring interoperability across regions[2][9].

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Patent Expirations and Generic Competition

Timeline of Generic Entries

The expiration of patents held by innovators like Exela Pharma Sciences (Akovaz®) has catalyzed generic competition. Sandoz Inc pioneered the first generic approval in 2017, followed by Amneal Pharmaceuticals (2019) and Fresenius Kabi (2025)[7]. These entries have diversified the market, with Eugia Pharma Specialities Ltd (India) and Xiromed LLC (US) introducing cost-effective alternatives[4][7].

Notably, Nexus Pharmaceuticals secured a patent in 2021 for EMERPHED®, a ready-to-use prefilled syringe, combining innovation with regulatory compliance[8][14]. This product’s launch reduced preparation errors in surgical settings, as validated by a Medical College of Wisconsin study[14].

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Market Trends and Product Innovations

Shift Toward Ready-to-Use Formulations

The market has pivoted from traditional vials to user-friendly formats. Hikma Pharmaceuticals’ 25 mg/5mL prefilled syringe (launched in 2024) and Nevakar Injectables’ 5 mg/mL prefilled vial (2022) exemplify this trend[10][11]. These products address clinical demands for efficiency, particularly in operating rooms where rapid administration is critical.

“The granting of this patent is the culmination of many years of scientific development and the hard work of our dedicated team.”
— Shahid Ahmed, Chief Scientific Officer, Nexus Pharmaceuticals[8]

IQVIA data reveals that prefilled syringes now account for 40% of ephedrine sulfate sales in the U.S., driven by their ease of use and reduced contamination risk[10][14].

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Global Distribution Networks

Export Hubs and Key Markets

India remains the epicenter of ephedrine sulfate API production, with Malladi Drugs and Embio Limited exporting to over 50 countries[9]. The U.S. and EU dominate finished-product imports, while emerging markets like Nigeria and Ukraine rely on Indian suppliers for bulk APIs[9][12]. Volza’s export data highlights Sri Lanka and Brazil as growing destinations, with shipments increasing by 15% annually[9].

GNH India (a WHO GDP-certified distributor) exemplifies the role of intermediaries, bridging manufacturers with hospitals in regions lacking local production[12]. Their cold-chain logistics ensure stability for temperature-sensitive injectables[12].

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Challenges in the Supply Chain

Regulatory Scrutiny and Supply Risks

Ephedrine sulfate’s status as a DEA List I chemical in the U.S. imposes stringent controls on sourcing and distribution[6]. Manufacturers must navigate complex licensing requirements, delaying time-to-market for new entrants. Additionally, API price volatility—often influenced by raw material shortages—has led to periodic stockouts in regions like Sub-Saharan Africa[9][12].

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Future Outlook and Strategic Recommendations

Opportunities in Biosimilar and Niche Formulations

With 17 patents set to expire by 2030, opportunities for biosimilars in hypotensive therapy are vast[7]. Companies like Fresenius Kabi are investing in lyophilized powders and combination products targeting postoperative care[7][11]. Concurrently, expanding GMP certification in Southeast Asia could alleviate supply bottlenecks, with countries like Vietnam emerging as alternative production hubs[9].

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Key Takeaways

1. India dominates API production, with Malladi Drugs and Pharm-RX Chemical leading in USDMF and CEP certifications.
2. Prefilled syringes are reshaping market dynamics, offering clinical advantages over traditional vials.
3. Patent expirations post-2025 will accelerate generic competition, particularly in North America and Europe.
4. Regulatory compliance remains a critical barrier, necessitating robust DMF and CoA frameworks.

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FAQs

1. Which companies produce ready-to-use ephedrine sulfate injections?
   Nexus Pharmaceuticals (EMERPHED®) and Hikma Pharmaceuticals offer prefilled syringes, while Xiromed LLC markets a generic vial[4][10][14].

2. How does GMP certification impact supplier selection?
   GMP ensures adherence to quality standards, with certifications like WHO GMP facilitating exports to emerging markets[2][3][6].

3. What are the key challenges in ephedrine sulfate distribution?
   DEA regulations, API price fluctuations, and cold-chain logistics pose significant hurdles[6][9][12].

4. Which regions are emerging as new export hubs?
   Vietnam and Indonesia are investing in GMP-compliant facilities to reduce reliance on Indian suppliers[9].

5. How are patents influencing market competition?
   Expired patents have enabled generics, while new patents for delivery systems (e.g., prefilled syringes) drive innovation[7][8][14].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ephedrine-sulfate
2. https://www.pharmacompass.com/active-pharmaceutical-ingredients/ephedrine-sulfate
3. https://pharmaoffer.com/api-excipient-supplier/ephedrine-sulfate/gmp
4. https://xiromed.com/usa/2023/07/17/xiromed-llc-launches-estradiol-valerate-injection-usp-2/
5. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ephedrine-sulphate
6. https://www.spectrumchemical.com/ephedrine-sulfate-dea-list-i-chemical-usp-ep120
7. https://pharsight.greyb.com/ingredient/ephedrine-sulfate-patent-expiration
8. https://www.businesswire.com/news/home/20210817005708/en/Nexus-Pharmaceuticals-Receives-Patent-for-EMERPHED-Ready-To-Use-Ephedrine-Sulfate-Injection
9. https://www.volza.com/p/ephedrine/manufacturers/
10. https://www.hikma.com/news/hikma-launches-ephedrine-sulfate-injection-usp-in-the-us/
11. https://nevakar.com/nevakar-injectables-receives-u-s-fda-approval-of-ready-to-use-ephedrine-injection-in-a-prefilled-syringe/
12. https://www.gnhindia.com/products/us-ndc/ephedrine-sulfate-ephedrine-sulfate-17478-955/
13. https://www.hikma.com/media/1m3n01r4/ephedrine-pr-v1.pdf
14. https://www.nexuspharma.net/news-articles/nexus-pharmaceuticals-inc-receives-fda-approval-for-emerphed-r-ephedrine-sulfate-injection-pre-filled-syringe