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Suppliers and packagers for generic pharmaceutical drug: EPINASTINE HYDROCHLORIDE
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EPINASTINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Somerset Theraps Llc | EPINASTINE HYDROCHLORIDE | epinastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 090951 | ANDA | Somerset Therapeutics, LLC | 70069-008-01 | 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE | 2016-09-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Epinastine Hydrochloride
Introduction
Epinastine Hydrochloride is a selective antihistamine primarily used for allergy relief, including allergic conjunctivitis and rhinitis. It functions as a potent antagonist of H1 histamine receptors, providing antihistaminic effects with minimal sedative properties. The global demand for Epinastine Hydrochloride has surged owing to its efficacy and safety profile, prompting pharmaceutical companies and API (Active Pharmaceutical Ingredient) manufacturers to establish diverse supply channels. This article identifies and analyzes the leading suppliers of Epinastine Hydrochloride, reviewing their manufacturing capacities, geographic presence, and compliance standards to assist industry stakeholders in sourcing and strategic planning.
Market Overview of Epinastine Hydrochloride Suppliers
The supply chain of Epinastine Hydrochloride encompasses several key players, spanning regions such as China, India, Europe, and the United States. China dominates as the primary manufacturing hub due to its extensive chemical and pharmaceutical API production infrastructure. India also plays a pivotal role, complemented by reputable European and U.S.-based suppliers focusing on quality and regulatory compliance.
Major Suppliers of Epinastine Hydrochloride
1. Zhejiang Linghuan Pharmaceutical Co., Ltd. (China)
Zhejiang Linghuan Pharmaceutical is a prominent Chinese manufacturer specializing in antihistamines and other APIs. With GMP certification and advanced synthesis capabilities, the company supplies Epinastine Hydrochloride to global markets. Their rigorous quality management system ensures compliance with international standards like USP and EP. Their strategic position in China affords competitive pricing and reliable delivery schedules.
Key Features:
- GMP-certified facilities
- Extensive export credentials
- Certification adherence (USP, EP)
2. Aarti Drugs Ltd. (India)
Aarti Drugs, based in Maharashtra, India, is recognized for its comprehensive API portfolio, including Epinastine Hydrochloride. The company leverages robust R&D and manufacturing processes aligned with WHO-GMP standards. It caters to domestic and international clients, with ISO 9001 certification reinforcing its quality commitments. The Indian market's favorable pricing and regulatory environment make Aarti Drugs a preferred supplier for many global pharmaceutical firms.
Key Features:
- WHO-GMP certified
- Integrated supply chain
- Focus on quality assurance
3. Jiangxi Huangxin Pharmaceutical Co., Ltd. (China)
Specializing in the production of antihistamine APIs, Jiangxi Huangxin Pharmaceutical has established itself as a reliable supplier for Epinastine Hydrochloride. The company benefits from China's supportive API export policies and possesses inspection-ready manufacturing facilities targeting markets in Europe and North America.
Key Features:
- Modern manufacturing infrastructure
- Dedicated R&D division
- Certification for international markets
4. TCI Chemicals (India and Global)
While primarily a chemical distributor, TCI Chemicals operates globally, sourcing and distributing high-quality APIs including Epinastine Hydrochloride. Their extensive distribution network ensures timely product delivery, strong quality control systems, and compliance with international regulatory standards.
Key Features:
- Global supply network
- High-quality standards
- Compliance with regulatory agencies
5. Sigma-Aldrich (U.S. / Europe)
Sigma-Aldrich, now a part of Merck, offers pharmaceutical-grade Epinastine Hydrochloride primarily for research and development purposes. Their products are ISO-certified and adhere to strict regulatory standards, making them ideal for pharmaceutical formulation R&D, toxicity testing, and quality validation.
Key Features:
- Pharmaceutical-grade API
- Extensive regulatory documentation
- Supply for research and clinical trials
Emerging Suppliers and Market Trends
Besides the established players, new entrants from China and India are increasing their presence by investing in advanced synthesis technology and quality control systems. There's a rising trend towards API manufacturers obtaining international certifications (e.g., ISO, cGMP, COS) to penetrate regulatory markets like the EU and U.S.
Additionally, the global shift towards API transparency and supply chain security encourages manufacturers to seek suppliers with transparent sourcing, strong compliance records, and environmental responsibility. Notable recent developments include the integration of sustainable practices in API manufacturing, which is increasingly influencing supplier selection.
Regulatory Considerations
Suppliers of Epinastine Hydrochloride must comply with stringent regulatory frameworks, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmacopoeial standards (USP, EP). Verification of GMP certification and batch-specific documentation is critical for downstream pharmaceutical manufacturing, especially for drugs intended for human use.
Supplier Selection Criteria
When evaluating suppliers, companies should consider the following:
- Regulatory compliance: Certifications like GMP, cGMP, ISO, and CE marking.
- Quality control: Batch consistency, purity levels, and documentation accuracy.
- Manufacturing capacity: Ability to meet current and future demand volumes.
- Lead times: Delivery reliability and flexibility.
- Pricing and payment terms: Competitive pricing aligned with quality standards.
- Supply chain transparency: Traceability and environmental responsibility.
Conclusion
The supply landscape for Epinastine Hydrochloride encompasses a mix of established Chinese and Indian manufacturers, advanced European and U.S. suppliers, and emerging players focused on innovation and compliance. For pharmaceutical companies, selecting a supplier hinges on stringent quality assurance, adherence to regulatory standards, reliable capacity, and supply chain transparency. Strategic relationships with reputable suppliers can mitigate risks, ensure consistent drug supply, and facilitate regulatory approvals globally.
Key Takeaways
- China and India dominate the Epinastine Hydrochloride API supply chain, offering cost-effective options.
- Regulatory compliance (GMP, ISO) is paramount for manufacturers to access global markets.
- Emerging suppliers with sustainable and transparent practices are reshaping supply chain dynamics.
- Establishing robust quality control processes and verifying certifications reduce risks in sourcing APIs.
- Building strategic partnerships with verified suppliers enhances supply chain resilience and global market access.
FAQs
1. What are the primary regions manufacturing Epinastine Hydrochloride?
China and India are the leading manufacturers due to their extensive chemical synthesis capabilities and large-scale production infrastructure.
2. How can pharmaceutical companies verify the quality of Epinastine Hydrochloride suppliers?
By reviewing regulatory certifications (GMP, ISO), requesting batch test reports, and conducting supplier audits when feasible.
3. Are there any FDA-approved suppliers of Epinastine Hydrochloride?
Most Chinese and Indian suppliers comply with GMP standards suitable for export, but FDA approval is typically applicable to finished product manufacturers, not raw API suppliers.
4. What are the common quality standards for Epinastine Hydrochloride APIs?
United States Pharmacopeia (USP), European Pharmacopoeia (EP), and International Organization for Standardization (ISO) standards are commonly referenced.
5. How is the trend towards sustainable manufacturing affecting Epinastine Hydrochloride suppliers?
Manufacturers adopting environmentally responsible practices and transparency are gaining preference, aligning with global ESG (Environmental, Social, Governance) initiatives.
References
- [1] Pharmaceutical Technology. “API manufacturing market insights.” 2022.
- [2] European Medicines Agency. “Guidelines on active pharmaceutical ingredients (API).” 2021.
- [3] U.S. Food and Drug Administration. “Regulation of APIs and manufacturing standards.” 2022.
- [4] World Health Organization. “Prequalification of pharmaceuticals and APIs.” 2021.
- [5] Industry reports on antihistamine APIs,MarketWatch, 2022.
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