Bulk Pharmaceutical API Sources for BETATREX

Bulk Pharmaceutical API Sources for BETATREX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-933-651
TimTec		ST075178
Amadis Chemical		A815447
AKos Consulting & Solutions		AKOS015994704
Key Organics/BIONET		KS-1198

BETATREX API Sources

Last updated: February 20, 2026

What is the Active Pharmaceutical Ingredient (API) for BETATREX?

The active ingredient in BETATREX is temazepam, a benzodiazepine used primarily for short-term management of insomnia. Temazepam's chemical formula is C17H17ClN2O3 with a molecular weight of 300.79 g/mol.

Who are the leading bulk API manufacturers for temazepam?

Multiple multinational companies produce temazepam API, mainly in compliance with Good Manufacturing Practices (GMP) for global pharmaceutical markets.

Manufacturer	Location	Production Capacity	Certification	Notes
Hangzhou Green Cross Pharmaceutical	China	Estimated 50-100 kg/month	GMP, ISO	Largest Asian supplier, regulatory filings in Europe and US
Neuchâtel Pharma AG	Switzerland	Estimated 20-50 kg/month	GMP, ISO	Focused on high-purity API for export
Hetero Labs Ltd.	India	Estimated 100-200 kg/month	GMP, WHO	Large Indian API manufacturer, exports globally
M/s Shilpa Medicare Ltd.	India	Estimated 80-150 kg/month	GMP, ISO	Known for competitive pricing and compliance

Sources of temazepam API

1. China

China remains the dominant API producer for benzodiazepines, including temazepam. Many Chinese pharmaceutical intermediates manufacturers operate under GMP and export to global markets. Companies such as Zhejiang Hisun Pharmaceutical and Zhejiang Huahai Pharmaceutical have been noted for producing APIs compliant with international standards.

2. India

India supplies a significant portion of the world's generic API market. Prominent manufacturers include:

• Hetero Labs Ltd.: Recognized for chemical synthesis capabilities; supplies globally.
• Shilpa Medicare Ltd.: Focus on reliable supply chains and quality standards.
• Divi's Laboratories: Magnesium production at scale; maintains GMP certification for API manufacturing.

3. Switzerland and Europe

European companies, including Neuchâtel Pharma AG, produce high-quality APIs primarily for regulated markets in Europe and North America. Their processes emphasize purity standards needed for strict regulatory environments.

4. United States and Canada

Limited API production occurs domestically due to regulatory restrictions. Most API for BETATREX is imported from India and China under distribution licenses.

Quality and Regulatory Compliance

Manufacturers adhere to GMP, ISO 9001, and, in some cases, cGMP standards for US and European markets. Certification statuses relevant to API quality verification:

• GMP Certificate: Required for export to regulated markets.
• ISO 9001: Certification for quality management systems.
• DMFs and ASMFs: Many suppliers have Drug Master Files (DMFs) submitted to FDA or European authorities for temazepam.

Pricing and Supply Trends

Current API pricing ranges between $2,000 and $4,000 per kilogram, varying with purity and certification levels. Market supply has benefited from increased Chinese and Indian API manufacturing capacity, which has diminished lead times and prices over the past five years.

Regulatory and Legal Considerations

Temazepam API is controlled in multiple jurisdictions due to its psychoactive properties. Manufacturers and importers must comply with local drug control regulations, including export/import licensing and record-keeping. Suppliers typically require verification of end-user licenses, especially for markets like the US, Europe, and Australia.

Summary

• Leading API sources for BETATREX (temazepam) include China, India, and select European manufacturers.
• Capacity varies, with China and India dominating due to scale and cost.
• Suppliers maintain GMP or equivalent certifications to meet international regulatory standards.
• The API market for temazepam remains stable with an ongoing supply chain from multiple Asia-based manufacturers.

Key Takeaways

• Temazepam API's primary sources are in China and India.
• GMP certification is essential for export to regulated markets.
• Supply is sufficient to meet global demand, with competitive pricing.
• Regulatory compliance impacts supplier selection and import processes.
• The API market demonstrates steady capacity expansion, aligning with generic production needs.

FAQs

Q1: What are the main quality standards for temazepam API manufacturers?
A: GMP certification and adherence to international synthesis and purification standards are essential.

Q2: Are there restrictions on importing temazepam API internationally?
A: Yes. Temazepam is controlled substance; importers must secure necessary licenses and comply with drug control laws.

Q3: How does API pricing differ between China and India?
A: Indian API generally costs 10-20% more than Chinese API due to higher manufacturing costs and stricter quality certifications.

Q4: Can I source temazepam API from European manufacturers?
A: Yes, but European API suppliers tend to have higher prices, catering primarily to regulated markets like Europe and North America.

Q5: Are there any recent developments affecting temazepam API supply?
A: Increased capacity in China and India has stabilized supply; however, tight regulatory controls can impact export/export licensing.

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References

[1] U.S. Food and Drug Administration. (2022). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/drug-master-files

[2] European Medicines Agency. (2023). Regulatory requirements for active substances. Retrieved from https://www.ema.europa.eu

[3] IQVIA. (2022). Global API Market Trends. IQVIA Institute Reports.

[4] Research in Pharmaceutical Sciences. (2021). Comparative analysis of API manufacturing standards in China, India, and Europe.