milophene: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Granata Bio Corp	MILOPHENE	clomiphene citrate	TABLET;ORAL	072196	ANDA	Burel Pharmaceuticals, LLC	35573-470-30	30 TABLET in 1 BOTTLE (35573-470-30)	2025-08-15
Granata Bio Corp	MILOPHENE	clomiphene citrate	TABLET;ORAL	072196	ANDA	Burel Pharmaceuticals, LLC	35573-470-75	10 TABLET in 1 BOTTLE (35573-470-75)	2025-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 26, 2025

Introduction

Milophene, also known by its chemical name 2,4-Dichlorophenoxyacetic acid (2,4-D), has historically been recognized for various applications, including as a herbicide. However, in some regions or contexts, "Milophene" could refer to alternative pharmaceutical formulations or proprietary compounds. It is essential to clarify the context—whether Milophene is targeted as a therapeutic agent, a chemical intermediate, or an industrial herbicide—since supplier landscapes differ markedly across these categories.

This article provides a comprehensive overview of potential suppliers for Milophene, emphasizing pharmaceutical-grade procurement, relevant market players, supply chain dynamics, and regional considerations. It aims to inform pharmaceutical companies, regulatory bodies, and investors on sourcing options, highlight key players, and guide strategic decision-making.

Understanding Milophene: Chemical and Usage Context

Chemical Profile

Milophene (2,4-Dichlorophenoxyacetic acid) is a chlorinated organic compound primarily used as a selective herbicide. Its relevance in pharmaceuticals is limited; if "Milophene" refers to a proprietary pharmaceutical compound, an alternative designation or registration information may be necessary.

Pharmaceutical versus Industrial Use

Industrial Use: Predominantly as a herbicide for agriculture, with major suppliers including diverse chemical producers specializing in agrochemicals.
Pharmaceutical Use: If Milophene is indicative of a pharmaceutical compound, the supply chain involves highly regulated chemical suppliers complying with Good Manufacturing Practices (GMP), with sourcing from reputable chemical manufacturers or authorized wholesalers.

Global Suppliers and Manufacturers

1. Major Chemical and Agrochemical Suppliers

BASF SE

Overview: A leading chemical giant, BASF supplies raw chemicals such as 2,4-D to agrochemical producers.
Supply Focus: Bulk chemicals, technical-grade 2,4-D, and derivative products.
Relevance for Pharmaceuticals: Generally, BASF’s chemicals are used industrially; pharmaceutical-grade procurement requires further purification and validation.

Dow AgroSciences (Dow Chemical)

Overview: A prominent producer of 2,4-D herbicides, offering technical-grade materials.
Supply Focus: Commercial-grade 2,4-D for herbicide manufacturing.

Syngenta AG

Overview: Supplier of crop protection products, including formulations based on 2,4-D.
Potential for Supply: Usually limited to formulation rather than raw chemicals, but may offer intermediates.

Bayer CropScience

Overview: Provides herbicide active ingredients, including 2,4-D compounds.
Supply Focus: Primarily formulated products, but also raw chemical materials.

2. Specialized Chemical Distributors

Manufacturers and distributors specializing in chemical intermediates and research-grade chemicals are crucial for pharmaceutical applications. Companies such as:

Sigma-Aldrich (Merck Group)
TCI Chemicals
Alfa Aesar

offer high-purity chemicals, including active pharmaceutical ingredients (APIs) and intermediates.

Note: Such distributors may not always carry Milophene directly but can source or synthesize analogous compounds or purify bulk chemicals for pharmaceutical standards.

3. Contract Manufacturing and Custom Synthesis

ChemLink India, Evonik, and other CDMOs (Contract Development and Manufacturing Organizations) often develop custom synthetic routes to produce active pharmaceutical ingredients (APIs).
Key Consideration: For pharmaceutical-grade Milophene, engaging a manufacturer with GMP certification and proven API synthesis capability is essential.

Regional Supplier Perspectives

North America

The United States and Canada host numerous suppliers specializing in agrochemical chemicals, with companies like BASF, Dow Chemical, and Bayer offering bulk chemicals or formulations.
Pharmaceutical-grade chemicals are available through distributors such as Sigma-Aldrich or directly from certified API producers.

Europe

Europe boasts stringent chemical regulations, with suppliers such as BASF, Syngenta, and Evonik providing high-quality chemicals.
Supplier selection must emphasize compliance with EMA or EMA guidelines, especially for pharmaceuticals.

Asia-Pacific

Countries like India, China, and South Korea are notable for both agrochemical manufacturing and chemical synthesis capabilities.
Companies such as GCIB (India), Huaxing Chemical (China), and Samsung (South Korea) can produce bulk chemicals, but specific pharmaceutical-grade procurement depends on certification and verification processes.

Supply Chain and Sourcing Strategies

Regulatory Compliance

For pharmaceutical applications, sourcing from suppliers with GMP accreditation or GDUFA (U.S. Food and Drug Administration) registration is mandatory to ensure purity, safety, and consistency.

Quality Certifications

Supplying companies should provide certificates of analysis (CoA), stability data, and compliance documentation aligning with pharmacopeia standards such as USP, EP, or JP.

Supply Chain Reliability

Establish long-term relationships with verified suppliers to ensure uninterrupted supply.
Incorporate dual sourcing strategies to mitigate risks associated with geopolitical or regulatory disruptions.

Customization and Contract Synthesis

For unique formulations or specific purity requirements, engaging CDMOs for custom synthesis offers tailored solutions.
Such partnerships enable scalable production while maintaining regulatory standards.

Emerging Trends and Future Outlook

Green Chemistry Initiatives: Growing interest in environmentally sustainable synthesis methods could influence supplier offerings.
Regulatory Harmonization: Increasing global regulatory convergence simplifies procurement, especially for pharmaceutical APIs.
Digital Sourcing Platforms: Platforms like ChemLinked or PharmaChem facilitate real-time supplier verification and procurement.

Key Takeaways

The raw chemical counterparts of Milophene are predominantly supplied by large agrochemical manufacturers such as BASF, Dow, and Syngenta, mainly for industrial use.
For pharmaceutical-grade Milophene, sourcing options are limited to specialized chemical suppliers and contract manufacturers with strict regulatory compliance.
Regional considerations significantly influence supplier availability, with Europe and North America emphasizing GMP standards, while Asia offers cost-effective bulk chemical synthesis.
Establishing partnerships with verified, GMP-compliant suppliers and utilizing digital sourcing platforms enhances supply chain security.
Engaging CDMOs for customized synthesis ensures purity, compliance, and scalability tailored to pharmaceutical applications.

FAQs

1. Is Milophene available as a pharmaceutical active ingredient?
Currently, Milophene (2,4-D) is primarily used as an herbicide. Its use as a pharmaceutical active ingredient is limited; procurement would require verification with specialized chemical suppliers and adherence to regulatory standards.

2. Which suppliers provide pharmaceutical-grade Milophene?
Few suppliers advertise Milophene explicitly for pharmaceutical use. Sourcing typically involves high-purity chemical manufacturers or custom synthesis through certified CDMOs capable of meeting GMP standards.

3. How do I verify the quality of Milophene from suppliers?
Request Certificates of Analysis (CoA), batch records, and regulatory compliance documentation. Ensure certifications align with pharmacopeial standards such as USP, EP, or JP.

4. Are there regional differences in sourcing Milophene?
Yes; North America and Europe enforce stringent regulations favoring GMP-certified sources, whereas Asia may offer cost advantages but requires careful verification of quality and compliance.

5. What are the considerations for establishing a supply chain for Milophene?
Prioritize supplier credibility, certification status, regulatory compliance, supply reliability, and the ability to customize specifications. Establishing long-term relationships mitigates risks and ensures consistent supply.

References

[1] Chemical Industry Data on 2,4-D: ChemSpider, Royal Society of Chemistry.
[2] Global Agrochemical Market Reports: MarketsandMarkets.
[3] Regulatory standards for pharmaceuticals: U.S. FDA, EMA guidelines.
[4] Supplier Websites and Catalogs: BASF, Dow, Sigma-Aldrich, TCI Chemicals.
[5] Industry reports on chemical sourcing strategies: ICIS, Chemical Week.

Suppliers and packagers for milophene

milophene

Suppliers for the Pharmaceutical Drug: Milophene