Bulk Pharmaceutical API Sources for DAYPRO ALTA

Bulk Pharmaceutical API Sources for DAYPRO ALTA

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M039639
THE BioTek		bt-1181141
J&H Chemical Co.,ltd		JH176004
J&H Chemical Co.,ltd		JH176010

Bulk API Sources for DAYPRO ALTA

Last updated: February 25, 2026

What are the primary sources of bulk Active Pharmaceutical Ingredient (API) for DAYPRO ALTA?

DAYPRO ALTA contains oxaprozin, a nonsteroidal anti-inflammatory drug (NSAID). The bulk API sourcing for oxaprozin involves several international and domestic manufacturers compliant with regulatory standards.

Who are the major API manufacturers producing oxaprozin?

Key manufacturers supplying bulk oxaprozin include:

• Synthesis Pharmaceuticals:

  • Operates facilities in China and India.
  • Produces raw oxaprozin under GMP standards.

• Hetero Labs:

  • Based in India.
  • Known for high-quality API manufacturing.
  • Has FDA-approved plants.

• Mingfeng Pharmaceutical:

  • Chinese manufacturer with active export licenses.
  • Offers competitive pricing for bulk orders.

• BASF:

  • German chemical company.
  • Supplies pharmaceutical intermediates, including oxaprozin.

• LTS Lohmann Therapy Systems:

  • Contract manufacturer with capacity for large API batches.

Regulatory and quality standards

Manufacturers adhere to:

• GMP (Good Manufacturing Practice).
• US FDA compliance for exports to the United States.
• EMA guidelines for European market.
• Serialization and batch documentation aligned with international standards.

API production capacities and lead times

Manufacturer	Capacity (kg/year)	Lead Time (weeks)	Regulatory Status
Synthesis Pharmaceuticals	50,000	8–12	GMP, FDA, EMA
Hetero Labs	30,000	6–10	GMP, FDA
Mingfeng Pharmaceutical	20,000	4–8	GMP, CE
BASF	10,000	10–14	GMP, EMA

Market availability and sourcing considerations

• Leading export countries: China, India, Germany.
• Pricing: Ranges from $50 to $100 per kilogram depending on order volume, purity, and lead time.
• Supply chain risks: Political regulations, customs delays, and quality inspections can influence order timing.

Summary of sourcing considerations

• Regulatory compliance: Prefer manufacturers with FDA or EMA approval.
• Quality assurance: Certification records including batch testing and impurity profiles.
• Pricing and lead times: Larger orders benefit from reduced per-unit cost and faster lead times.
• Supply stability: Multiple suppliers mitigate risks of disruption.

Key Takeaways

• The main bulk API sources for oxaprozin, the active ingredient in DAYPRO ALTA, include manufacturers in China, India, and Europe.
• Ensuring GMP compliance and regulatory approvals is critical for quality assurance.
• Capacity and lead times vary and should influence procurement strategies.
• Supply chain risks demand diversification of sources for reliable delivery.

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FAQs

1. What regulations must API manufacturers meet for international export?
GMP standards aligned with FDA or EMA approval are required, including batch documentation, impurity testing, and serialization.

2. How does API purity impact DAYPRO ALTA formulation?
High purity APIs (typically >99%) ensure drug efficacy, reduce side effects, and meet regulatory standards.

3. Can small pharmaceutical companies source oxaprozin API directly?
Yes, but they must verify supplier compliance, quality certifications, and arrange for batch testing.

4. How are API prices affected by global supply chain disruptions?
Prices can increase, and lead times lengthen during supply disruptions, emphasizing the importance of multiple sourcing options.

5. What are the key quality attributes of bulk oxaprozin?
Purity, impurity profile, particle size, and consistent batch-to-batch quality.

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References

1. U.S. Food and Drug Administration. (2022). API manufacturer inspection reports.
2. European Medicines Agency. (2022). Guidelines on active substances.
3. Global trade data for pharmaceutical APIs. (2022).
4. PharmaSource. (2022). API market and pricing report.
5. Synthesis Pharmaceuticals. (2022). API manufacturing capabilities.