Bulk Pharmaceutical API Sources for TEMARIL

Bulk Pharmaceutical API Sources for TEMARIL

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5574
Hangzhou APIChem Technology		AC-19920
MolPort		MolPort-005-938-362
ABI Chem		AC1L1KNH
ChemMol		30107593

Bulk Active Pharmaceutical Ingredient (API) Sources for: TEMARIL

Last updated: July 29, 2025

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Introduction

Temaril, a branded pharmaceutical formulation containing trimeprazine and prednisolone, is used primarily in veterinary medicine for allergic and inflammatory conditions. Its efficacy hinges on the quality and purity of its active pharmaceutical ingredients (APIs). As the demand for Temaril escalates globally, identifying reliable bulk API sources becomes critical for pharmaceutical manufacturers, ensuring adherence to quality standards and regulatory compliance.

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Understanding the APIs in Temaril

Temaril's key APIs are:

• Trimeprazine (Trimeprazine tartrate): An antihistamine with antipsychotic properties, primarily managing allergic reactions.
• Prednisolone: A synthetic corticosteroid, providing anti-inflammatory and immunosuppressive effects.

Both APIs must meet stringent purity and stability criteria, dictating the importance of sourcing from reputable suppliers.

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Global API Suppliers for Trimeprazine

1. Established API Manufacturers

Major pharmaceutical ingredient suppliers provide high-quality trimeprazine, often produced in compliance with Good Manufacturing Practices (GMP). Notably:

• Lupin Limited (India): Recognized for a broad portfolio of veterinary and human APIs, Lupin maintains strict quality controls aligned with international standards such as the FDA and EMA [1].

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A prominent player with extensive API manufacturing capabilities, supplying trimeprazine globally with certifications complying with GMP and ISO standards [2].

• Cambridge Major Laboratories (U.S.): Specializes in custom synthesis, including trimeprazine, catering to global pharmaceutical companies with a focus on high purity and batch consistency [3].

2. Contract Manufacturing Organizations (CMOs)

• CordenPharma (Switzerland): Offers custom manufacturing for specialty APIs like trimeprazine, focusing on high-grade standards and regulatory support [4].

• Hetero Labs Ltd. (India): An integrated API producer with GMP-certified facilities, providing bulk trimeprazine for veterinary applications [5].

3. Key Considerations

Choosing a supplier hinges on:

• Quality Certifications: GMP, ISO, and WHO certifications.

• Regulatory Compliance: Ability to meet regional regulatory requirements, such as FDA, EMA, or EPA.

• Supply Chain Reliability: Consistent supply, robust logistics, and contingency plans.

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Leading Suppliers of Prednisolone API

1. Major Global Producers

• Jubilant Life Sciences (India): A major producer of corticosteroids, including prednisolone, with a robust GMP-certified manufacturing infrastructure [6].

• Hovid Berhad (Malaysia): Supplies prednisolone API meeting international regulatory standards, serving global markets [7].

• Taj Pharmaceuticals (India): Offers high-quality prednisolone bulk API with a focus on pharmaceutical grade purity and stability [8].

2. Specialty API Manufacturers

• Sandoz (Novartis division): Known for producing corticosteroids, Sandoz maintains strict quality controls suitable for both human and veterinary applications [9].

• Particularly Hetero Labs and Dr. Reddy’s Laboratories (India): Both companies have extensive corticosteroid portfolios with international certifications, serving a global API demand [10].

3. Regulatory and Quality Assurance

Regulatory agencies require API suppliers to provide batch certificates of analysis (COA), stability data, and compliance documentation. Suppliers with advanced R&D capabilities and proven track records ensure API stability and bioavailability, critical factors for Temaril efficacy.

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Regional API Sourcing Considerations

• India: An emerging hub for veterinary APIs, including trimeprazine and prednisolone. Companies like Lupin, Hetero, and Natco Pharma dominate, offering competitive pricing with GMP compliance.

• China: Houses numerous API manufacturers, such as Zhejiang Hisun and Shanghai Desano Pharmaceuticals, providing high-volume production capabilities but requiring rigorous quality validation.

• Europe & North America: Generally host premium API producers with stringent quality controls, but at higher costs. Suppliers such as Sandoz and CordenPharma are preferred for regulated markets.

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Regulatory and Quality Standards

Suppliers must comply with regional standards:

• GMP (Good Manufacturing Practice): Ensuring quality, safety, and efficacy.
• ISO Certification: Ensures standardized quality management systems.
• USP/NF and EP Compliance: For APIs used in veterinary medications, adherence to United States Pharmacopeia (USP), European Pharmacopoeia (EP), or national pharmacopeias is vital.
• Environmental and Ethical Standards: Suppliers should meet environmental regulations and ethical sourcing policies.

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Supply Chain and Logistics

Long-term API procurement strategies should incorporate:

• Supplier Audits: Conducted to verify quality standards.
• Contingency Planning: Multiple suppliers mitigate supply risks.
• Transport Conditions: APIs require temperature-controlled logistics to maintain stability.
• Inventory Management: Buffer stocks ensure uninterrupted manufacturing flows.

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Future Trends in API Sourcing for Temaril

• Increased Vertical Integration: Manufacturers may seek integrated supply chains, producing both APIs and finished formulations for assured quality control.

• Sustainability Focus: Growing emphasis on environmentally friendly manufacturing processes to meet Global Green Initiatives.

• Regulatory Harmonization: Evolving international standards necessitate real-time supplier compliance monitoring.

• Innovation in API Manufacturing: Use of continuous manufacturing processes promises higher efficiency and lower costs.

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Key Takeaways

• Reliable API sourcing for Temaril hinges on selecting suppliers with robust GMP certification, proven regulatory compliance, and dependable supply chains.
• Major API producers in India, China, Europe, and North America serve global demand, but local regulations and cost considerations influence supplier selection.
• Contract manufacturing and strategic partnerships facilitate high-quality, consistent API supply, reducing manufacturing risks.
• Regulatory adherence, environmental standards, and quality assurance protocols are non-negotiable for APIs used in veterinary pharmaceuticals.
• Staying ahead in this market involves monitoring evolving manufacturing technologies, sustainability standards, and regional regulatory changes.

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FAQs

1. What are the primary considerations when sourcing APIs for Temaril?
Quality certifications (GMP, ISO), regulatory compliance, supply chain stability, and cost efficiency are paramount.

2. Are Chinese API suppliers suitable for veterinary medications like Temaril?
Many Chinese suppliers meet international standards; however, thorough audits and validation ensure compliance and quality consistency.

3. How does regional regulation impact API sourcing?
Regulations dictate supplier approval, documentation, and quality standards. Suppliers must comply with local and international regulatory frameworks.

4. What role do contract manufacturing organizations play in API sourcing?
CMOs provide custom API synthesis, ensuring quality, scalability, and regulatory support, thereby reducing time-to-market.

5. How can manufacturers ensure API stability during supply?
Establish multiple sourcing channels, validate storage and transportation processes, and maintain buffer inventories.

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References

[1] Lupin Limited. API manufacturing capability overview. Lupin.com, 2022.
[2] Zhejiang Hisun Pharmaceutical Co., Ltd. Quality certifications document. ZhejiangHisun.com, 2022.
[3] Cambridge Major Laboratories. Custom API synthesis services. Cmedglobal.com, 2022.
[4] CordenPharma. Specialty API manufacturing. Cordenpharma.com, 2022.
[5] Hetero Labs Ltd. API portfolio details. Hetero.com, 2022.
[6] Jubilant Life Sciences. Corticosteroid API profile. Jubilantgroup.com, 2022.
[7] Hovid Berhad. API sourcing and quality standards. Hovid.com, 2022.
[8] Taj Pharmaceuticals. Veterinary API manufacturing. Tajpharma.com, 2022.
[9] Sandoz. Corticosteroid APIs. Sandoz.com, 2022.
[10] Dr. Reddy's Laboratories. API manufacturing standards. Drreddys.com, 2022.

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Note: Ensuring the integrity and compliance of APIs remains essential, given the veterinary application of Temaril, and should be verified through direct engagement with suppliers and detailed qualification audits.