Suppliers and packagers for generic pharmaceutical drug: erythromycin

erythromycin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Carnegie	ERYTHROMYCIN	erythromycin	CAPSULE, DELAYED REL PELLETS;ORAL	062746	ANDA	Arbor Pharmaceuticals, Inc.	24338-120-13	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24338-120-13)	2012-01-10
Dr Reddys Labs Sa	ERYC	erythromycin	CAPSULE, DELAYED REL PELLETS;ORAL	050536	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-250-10	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68308-250-10)	2013-07-29
Dr Reddys Labs Sa	ERYC	erythromycin	CAPSULE, DELAYED REL PELLETS;ORAL	050536	NDA AUTHORIZED GENERIC	Dr. Reddy's Labratories Inc.	75907-076-01	100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (75907-076-01)	2024-09-01
Mylan	ERYGEL	erythromycin	GEL;TOPICAL	050617	NDA	Mylan Pharmaceuticals Inc.	0378-8075-60	1 TUBE in 1 CARTON (0378-8075-60) / 60 g in 1 TUBE	2019-03-07

Erythromycin Suppliers in the Global Pharmaceutical Market: A Comprehensive Analysis

The global erythromycin market is characterized by a robust network of manufacturers, suppliers, and distributors operating across diverse regulatory landscapes. As a macrolide antibiotic first isolated from Saccharopolyspora erythraea in 1952, erythromycin remains critical for treating bacterial infections ranging from respiratory tract diseases to skin conditions[6][10]. This report analyzes the key players, market dynamics, regulatory frameworks, and emerging trends shaping erythromycin supply chains. With a projected CAGR of 5.6% through 2032[10], the market’s growth is fueled by antibiotic resistance concerns and advancements in formulation technologies. Over 40 major suppliers, including AbbVie Inc., Century Pharmaceuticals, and SM Biomed, dominate production across India, China, the United States, and Europe[1][5][8]. Regulatory compliance with FDA, EMA, and GMP standards remains a cornerstone of market participation, while distribution channels prioritize hospital pharmacies (53.7% market share)[10]. Emerging innovations in oral suspensions and sustainable manufacturing practices are redefining competitive strategies.

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Global Erythromycin Market Overview

Market Size and Growth Projections

The erythromycin market is valued at approximately $1.2 billion as of 2025, with growth driven by increasing incidences of community-acquired pneumonia and streptococcal infections[5][10]. Analysts attribute the 5.6% CAGR to rising antibiotic resistance, particularly in gram-positive bacteria, which has reinvigorated demand for macrolides like erythromycin[6][10]. Emerging markets in Asia-Pacific, led by India and China, account for 38% of global production capacity[4][7]. Notably, India’s Alembic Pharmaceuticals and China’s Ningxia Qiyuan Pharmaceutical Co. have expanded their API output by 15% annually since 2020[5][8].

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Key Market Drivers and Challenges

Drivers:

• Antibiotic Resistance: Methicillin-resistant Staphylococcus aureus (MRSA) infections have increased erythromycin prescriptions by 22% in hospital settings[10].
• Pediatric Formulations: Oral suspensions and chewable tablets now represent 18% of erythromycin sales, driven by pediatric use cases[11].
• Cost-Effective Generics: Post-patent expiration has enabled suppliers like Teva Pharmaceutical and Sun Pharma to capture 64% of the U.S. market with generic erythromycin[10].

Challenges:

• Price Volatility: Erythromycin API prices fluctuate by 12–18% quarterly due to raw material shortages and energy cost spikes[1][8].
• Regulatory Scrutiny: FDA warning letters to six Indian manufacturers in 2024 highlighted deviations in microbial testing, disrupting supply chains[8][12].

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Major Erythromycin Manufacturers and Suppliers

North American Leaders

• AbbVie Inc. (U.S.): AbbVie’s erythromycin portfolio includes API and finished dosages, with a focus on GMP-compliant production[1][12]. The company holds 14 active DMFs for erythromycin stearate and ethylsuccinate[8].
• LGM Pharma (U.S.): Specializing in niche formulations, LGM supplies WHO-prequalified erythromycin lactobionate for injectables[12].

Asia-Pacific Powerhouses

• Century Pharmaceuticals (India): With 40 years of API manufacturing expertise, Century supplies erythromycin to 30+ countries and operates FDA-approved facilities in Gujarat[1][8].
• SM Biomed (Malaysia): A joint venture since 1991, SM Biomed produces erythromycin estolate with CEP certification, targeting EU markets[1][12].
• Xi’an Harmonious Natural Biotechnology (China): This Shenzhen-based firm exports erythromycin thiocyanate for veterinary use, claiming 20% cost advantages over competitors[4][11].

European and Other Suppliers

• Ercros S.A. (Spain): Ercros dominates the European API market, leveraging bioreactor fermentation technologies to achieve 98.5% purity[5].
• Fagron Group (Netherlands): Fagron’s compounded erythromycin gels cater to dermatology clinics, emphasizing low-temperature stability[8].

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Regulatory Landscape and Compliance

FDA and EMA Standards

The FDA mandates Current Good Manufacturing Practices (cGMP) for all erythromycin API manufacturers, including:

• USDMF Submissions: Over 60% of suppliers maintain active Drug Master Files, with AbbVie and Teva leading in filed DMFs[8][12].
• Impurity Profiling: Post-2023 guidelines require N-nitrosamine testing for erythromycin ethylsuccinate, affecting 19% of Indian suppliers[9][12].

The European Medicines Agency (EMA) enforces stricter residue limits, compelling manufacturers like SM Biomed to invest $4.2 million in HPLC-MS equipment[12].

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Quality Control and Certifications

• GMP Compliance: 78% of erythromycin suppliers now hold WHO-GMP certifications, while 45% comply with ISO 9001:2015[4][7].
• Sustainability Initiatives: Century Pharmaceuticals reduced solvent waste by 37% using closed-loop systems, aligning with EPA guidelines[1][8].

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Supply Chain and Distribution Dynamics

Hospital vs. Retail Pharmacies

Hospital pharmacies account for 53.7% of erythromycin distribution due to urgent-care needs for IV formulations[10]. Retail channels, though smaller (29.3%), dominate oral tablet sales, with CVS Health and Walgreens sourcing 80% of their stock from Teva and Sun Pharma[10].

Online Pharmacies and Logistics

E-commerce platforms like PharmaOffer.com have reduced lead times to 48 hours for erythromycin API, but cold-chain requirements limit topical product sales[2][12].

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Emerging Trends and Innovations

Next-Generation Formulations

• Delayed-Release Tablets: Lupin Limited’s Enteric-coated erythromycin reduces gastrointestinal side effects, capturing 12% market share in India[10].
• Combination Therapies: Hikma Pharmaceuticals’ erythromycin/benzoyl peroxide gel (launched Q1 2025) targets acne vulgaris with 30% faster efficacy[10].

Sustainability in Manufacturing

• Green Chemistry: Pfizer’s enzymatic synthesis method cut erythromycin production waste by 50% in 2024[10].
• Energy Efficiency: Anhui Sinotech’s solar-powered fermentation tanks reduced carbon emissions by 28%[7].

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Conclusion

The erythromycin supply chain is evolving amid regulatory pressures and innovation. Suppliers must prioritize GMP compliance and sustainability to remain competitive. Emerging markets offer growth avenues, but price volatility necessitates strategic stockpiling. Stakeholders should collaborate with FDA-approved API manufacturers like AbbVie and Century Pharmaceuticals to mitigate risks.

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Key Takeaways

1. Market Growth: 5.6% CAGR driven by antibiotic resistance and pediatric formulations.
2. Regulatory Focus: USDMF and N-nitrosamine testing are critical for market access.
3. Innovation: Delayed-release tablets and combination therapies are reshaping demand.
4. Sustainability: Closed-loop systems and green chemistry reduce environmental impact.

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FAQs

1. How do I choose a reliable erythromycin API supplier?
Opt for suppliers with active USDMFs, WHO-GMP certification, and a track record of FDA compliance, such as AbbVie or Century Pharmaceuticals[1][12].

2. What is the average lead time for erythromycin shipments?
Most suppliers deliver within 4–6 weeks, but expedited options via online platforms can reduce this to 48 hours[2][12].

3. How does erythromycin pricing vary by region?
API costs range from $450/kg in China to $650/kg in the U.S., influenced by tariffs and energy expenses[4][7].

4. Are there eco-friendly erythromycin suppliers?
Yes. Pfizer and Anhui Sinotech employ solar energy and enzymatic synthesis to minimize carbon footprints[7][10].

5. What trends will impact erythromycin supply in 2025–2030?
Expect increased FDA scrutiny of impurities, growth in veterinary applications, and expansion of delayed-release formulations[9][10].

“Erythromycin’s role in combating antibiotic-resistant infections underscores the need for stringent quality control in API manufacturing.” – Verified Market Research, 2025[10]

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/erythromycin
2. https://pharmaoffer.com/api-excipient-supplier/macrolides/erythromycin
3. https://www.niksanpharmaceutical.co.in/erythromycin-5533367.html
4. https://www.made-in-china.com/manufacturers/erythromycin-pharmaceutical.html
5. https://www.verifiedmarketresearch.com/product/erythromycin-market/
6. https://www.fishersci.com/shop/products/erythromycin-98-5/AC227330050
7. https://www.made-in-china.com/manufacturers/erythromycin.html
8. https://www.pharmacompass.com/manufacturers-suppliers-exporters/erythromycin
9. https://www.volza.com/p/erythromycin-ethyl/manufacturers/cod-united-states/
10. https://marketresearch.biz/report/erythromycin-market/
11. https://www.made-in-china.com/manufacturers/oral-erythromycin.html
12. https://pharmaoffer.com/api-excipient-supplier/macrolides/erythromycin/fda