PROMETH VC PLAIN pharmaceutical API fine chemical suppliers

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical	⤷ Get Started Free	2023-05-7C03311	⤷ Get Started Free
RR Scientific	⤷ Get Started Free	R6440204	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: July 30, 2025

Introduction

The formulation of PROMETH VC PLAIN, a combination medicinal product, involves the utilization of critical active pharmaceutical ingredients (APIs). The components traditionally include promethazine, vitamin C (ascorbic acid), and sometimes additional excipients for stabilization. This article explores the primary sources for bulk APIs relevant to PROMETH VC PLAIN, emphasizing procurement strategies, manufacturing considerations, and regulatory compliance to facilitate reliable supply, cost efficiency, and quality assurance.

Active Pharmaceutical Ingredients in PROMETH VC PLAIN

PROMETH VC PLAIN predominantly combines two APIs:

Promethazine Hydrochloride: An antihistamine with antiemetic and sedative properties.
Ascorbic Acid (Vitamin C): An antioxidant used to boost immune response and stabilize the formulation.

Understanding sources for these APIs is essential for pharmaceutical companies aiming to manufacture PROMETH VC PLAIN on a large scale.

Global API Suppliers for PROMETH VC PLAIN

1. Promethazine Hydrochloride

Major API producers for promethazine hydrochloride have established global manufacturing footprints, primarily in India, China, and Europe. Key suppliers include:

India:
- Divi’s Laboratories: Recognized for high-quality APIs, including promethazine salts. Their vertically integrated manufacturing ensures consistent quality and supply.
- Glenmark Pharmaceuticals: Offers robust API production with GMP compliance, serving both domestic and international markets.
- Vins affair: A prominent manufacturer with capacity for large-scale API production.
China:
- Tianyuan Pharmaceutical: Provides promethazine hydrochloride APIs, adhering to international quality standards.
- Shenzhen Beike Biotech Co., Ltd.: Known for rapid production and competitive pricing.
Europe:
- Dr. Reddy’s Laboratories (India-based with European distribution): Offers high-purity APIs for export and regulatory markets.

Regulatory considerations: Suppliers must demonstrate compliance with USP, EP, or other pharmacopoeial standards. Certifications like cGMP (current Good Manufacturing Practices) are essential.

2. Ascorbic Acid

Ascorbic acid remains among the most widely synthesized and globally available APIs due to its large industrial demand.

Leading suppliers include:

China:
- Yunnan Tin Company: One of the world’s significant producers, offering bulk ascorbic acid at competitive prices.
- Shandong Luba Chemical: Known for high-purity grade ascorbic acid suitable for pharmaceutical use.
India:
- Mitra Industries: Provides pharmaceutical-grade ascorbic acid meeting international standards.
- Vibcare Pharmaceuticals: Known for consistent supply and compliance with regulatory standards.
Europe and North America:
- BASF: Supplies high-quality ascorbic acid derivatives and standard USP-grade products.
- FMC Corporation: Offers pharmaceutical-grade ascorbic acid with robust quality controls.

Criteria for Selecting API Suppliers

Quality & Regulatory Compliance: Suppliers must comply with GMP and demonstrate adherence to pharmacopoeial standards.
Supply Chain Reliability: Long-standing track records and transparent supply chains reduce risk.
Pricing & Lead Time: Competitive pricing, coupled with short lead times, improves manufacturing efficiency.
Documentation & Certification: Valid Certificate of Analysis (CoA), Certificate of Suitability (CE), or Drug Master File (DMF) are essential for regulatory filings.
Environmental & Ethical Standards: Preference for suppliers adhering to environmental regulations and ethical sourcing practices.

Regional API Manufacturing Hubs

India: A dominant player with over 50% global API manufacturing share, driven by cost advantages and stringent quality norms.
China: Key in large-scale production of bulk APIs, often at lower costs, but with increasing regulatory scrutiny.
Europe & North America: Suppliers here focus on high-quality standards, often catering to regulatory markets requiring rigorous validation.

Emerging Trends in API Sourcing

Localization & Supply Chain Diversification: Global disruptions propel companies to diversify sources beyond traditional regions.
API Quality Standardization: Enhanced focus on harmonized standards and regulatory acceptance (e.g., WHO-GMP, U.S. FDA-approved).
Sustainable API Production: Growing demand for environmentally sustainable manufacturing processes.

Regulatory and Quality Assurance Considerations

GMP Certification: Ensures quality and safety of APIs; a non-negotiable requirement.
Quality Documentation: Detailed CoA, Material Safety Data Sheets (MSDS), stability data, and process validation reports.
Inspection & Audits: Regular site inspections and audits reinforce compliance and mitigate contamination risks.
Import Regulations: Suppliers should possess approved DMFs in target markets, such as the U.S. (FDA) or Europe (EMA).

Cost-Efficiency Strategies in API Procurement

Bulk Purchasing & Long-Term Contracts: Favorable for price negotiations.
API Exchanges & Consortia: Participating in industry consortia can ensure steady supply.
Local Sourcing: For regional markets, sourcing from nearby APIs reduces logistics costs and lead times.
Quality-First Approach: Ensuring API quality reduces downstream costs associated with batch failures or regulatory delays.

Conclusion

Reliable sourcing of APIs for PROMETH VC PLAIN hinges on balancing cost, quality, and regulatory compliance. Indian and Chinese API manufacturers stand out as primary suppliers due to their manufacturing capacity, cost advantage, and global reach. European and North American producers emphasize quality and regulatory stringency, suitable for markets with rigorous standards.

A strategic procurement plan entails supplier qualification, ongoing quality audits, and diversification to mitigate risks from geopolitical or supply chain disruptions. As the demand for PROMETH VC PLAIN continues to grow, establishing resilient API sourcing partnerships remains paramount for pharmaceutical companies aiming to maintain quality, compliance, and cost efficiency.

Key Takeaways

Major API suppliers for PROMETH VC PLAIN include reputable Indian, Chinese, European, and North American manufacturers.
Ensuring GMP compliance and thorough documentation is vital for regulatory acceptance.
Cost-effective procurement combines bulk purchasing, supplier diversification, and regional sourcing strategies.
Sustainable and environmentally conscious API manufacturing is increasingly influential in supplier selection.
Regular audits and quality assurance procedures are essential to maintain high standards in API sourcing.

FAQs

1. What are the primary considerations when choosing an API supplier for PROMETH VC PLAIN?
Quality compliance (GMP certification), reliable supply chain, regulatory alignment, cost, and environmental standards.

2. Are Indian API manufacturers suitable for bulk sourcing of promethazine and ascorbic acid?
Yes. Indian API producers like Divi’s Laboratories and Vins affair are well-recognized for high-quality APIs, GMP compliance, and cost competitiveness.

3. How does regulatory compliance influence API sourcing decisions?
Regulatory compliance ensures APIs meet pharmacopoeial standards and facilitates approval processes in target markets, reducing the risk of delays or rejections.

4. What emerging trends impact API sourcing strategies?
Global supply chain diversification, increased focus on sustainability, and harmonization of quality standards drive sourcing adjustments.

5. Can localized API sourcing reduce supply chain risks for PROMETH VC PLAIN?
Yes. Sourcing from nearby regions minimizes logistical delays, mitigates geopolitical risks, and can lower supply chain costs.

Sources

[1] Divi’s Laboratories. (2022). API Capabilities.
[2] Tianyuan Pharmaceutical. (2022). Product Portfolio & Quality Standards.
[3] Yunnan Tin Company. (2022). Ascorbic Acid Production & Supply Data.
[4] WHO-GMP Guidelines. (2021). Good Manufacturing Practices for API Production.
[5] U.S. FDA. (2022). Drug Master Files (DMF) for API Suppliers.

Bulk Pharmaceutical API Sources for PROMETH VC PLAIN