Suppliers and packagers for hemabate

hemabate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	HEMABATE	carboprost tromethamine	INJECTABLE;INJECTION	017989	NDA	Pharmacia & Upjohn Company LLC	0009-0856-05	1 mL in 1 AMPULE (0009-0856-05)	1979-01-09
Pfizer	HEMABATE	carboprost tromethamine	INJECTABLE;INJECTION	017989	NDA	Pharmacia & Upjohn Company LLC	0009-0856-08	10 AMPULE in 1 PACKAGE (0009-0856-08) / 1 mL in 1 AMPULE (0009-0856-05)	1979-01-09

Suppliers for Hemabate (Carboprost Tromethamine)

Last updated: February 19, 2026

Hemabate, the brand name for carboprost tromethamine, is a synthetic prostaglandin F2α analog used to control postpartum hemorrhage. Sourcing reliable suppliers for its active pharmaceutical ingredient (API) and key intermediates is critical for manufacturers. This analysis identifies major suppliers and examines their roles in the global pharmaceutical supply chain.

What are the primary suppliers of carboprost tromethamine API?

The manufacturing of carboprost tromethamine API is concentrated among a limited number of specialized chemical synthesis companies. These entities operate under stringent quality controls and regulatory compliance to meet pharmaceutical standards.

• AbbVie Inc.

  • As the originator and current marketer of Hemabate, AbbVie possesses internal manufacturing capabilities for carboprost tromethamine API. This direct control over API production ensures supply chain security for its branded product.
  • While specific production volumes are proprietary, AbbVie's capacity is designed to meet global demand for its approved indications.
  • AbbVie's manufacturing facilities are subject to FDA and other international regulatory body inspections.

• Gland Pharma Limited

  • Gland Pharma is a significant contract development and manufacturing organization (CDMO) that produces carboprost tromethamine API. The company supplies this API to multiple generic pharmaceutical manufacturers.
  • The company's website indicates a broad portfolio of injectables and sterile APIs, including prostaglandins.
  • Gland Pharma operates multiple manufacturing sites in India, which are approved by regulatory agencies including the US FDA, EMA, and others.
  • Specific production capacity for carboprost tromethamine is not publicly disclosed, but its role as a major API supplier suggests substantial capabilities.

• Other Contract Manufacturing Organizations (CMOs)

  • Several other CMOs globally may produce carboprost tromethamine API on a smaller scale or for specific regional markets. These suppliers typically specialize in complex organic synthesis.
  • Identification of these entities often requires direct inquiry and due diligence, as they may not publicly list all APIs in their active portfolios.
  • These CMOs operate under Good Manufacturing Practices (GMP) and often hold certifications from national regulatory authorities.

Which key intermediates are critical for carboprost tromethamine synthesis, and who supplies them?

The synthesis of carboprost tromethamine involves a multi-step process requiring specific chemical intermediates. The reliable sourcing of these precursors is paramount.

• Prostaglandin Core Structures:

  • The synthesis typically begins with protected cyclopentanone derivatives or other cyclic precursors that form the core structure of prostaglandins.
  • Suppliers of these advanced intermediates are often specialized fine chemical manufacturers. Examples include companies with expertise in stereoselective synthesis.
  • Key Intermediates: Specific cyclopentenone derivatives.
  • Potential Suppliers: Companies specializing in complex organic synthesis for the pharmaceutical industry. These can include companies in China, India, and Europe. Precise identification of these specific intermediate suppliers is often confidential due to contractual agreements.

• Side Chain Precursors:

  • The characteristic side chains of carboprost tromethamine (a hydroxylated C7 chain and an α,ω-dicarboxylic acid equivalent) are introduced through a series of controlled reactions.
  • Specific reagents and functionalized building blocks are required.
  • Key Intermediates: Various functionalized alkyl halides, aldehydes, or organometallic reagents.
  • Potential Suppliers: Global chemical suppliers offering reagents for organic synthesis, including large corporations and niche producers. Examples of companies that might supply such building blocks include Sigma-Aldrich (Merck KGaA), Thermo Fisher Scientific, and various custom synthesis providers.

• Tromethamine:

  • Tromethamine (tris(hydroxymethyl)aminomethane) is the counterion that forms the salt with carboprost. It is a commercially available bulk chemical.
  • Key Chemical: Tromethamine.
  • Major Suppliers: Widely available from numerous chemical distributors and manufacturers. Large-scale suppliers include:
    • BASF SE: A major global chemical producer with a diverse portfolio.
    • Merck KGaA (MilliporeSigma): Offers a broad range of laboratory and specialty chemicals.
    • Ajinomoto Co., Inc.: Known for amino acids and related compounds, tromethamine is within their scope.
  • Pharmaceutical-grade tromethamine requires specific purity standards and regulatory documentation.

What regulatory considerations impact carboprost tromethamine supply?

The supply of carboprost tromethamine API and finished drug product is heavily regulated to ensure patient safety and product efficacy.

• Good Manufacturing Practices (GMP):

  • All API manufacturing facilities must adhere to cGMP guidelines set forth by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.
  • These regulations cover facility design, equipment, personnel, quality control, and documentation.
  • Inspections by regulatory agencies are routine for API manufacturers supplying to major markets.

• Drug Master Files (DMFs):

  • API manufacturers typically submit DMFs to regulatory agencies. A DMF provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs.
  • Pharmaceutical companies using the API reference these DMFs in their drug applications (e.g., NDAs, ANDAs).
  • The DMF process facilitates regulatory review without requiring the API manufacturer to disclose proprietary information directly to the drug product applicant.

• Quality Agreements:

  • Formal Quality Agreements are established between API suppliers and drug product manufacturers. These agreements delineate the responsibilities of each party regarding quality control, change management, complaint handling, and regulatory compliance.

• Supply Chain Security and Traceability:

  • Increasingly, regulatory bodies are emphasizing supply chain security and traceability to prevent counterfeit drugs and ensure product integrity.
  • This includes tracking APIs from their source through to the finished product.

What are the geographical concentrations of carboprost tromethamine manufacturing?

The production of pharmaceutical APIs, including carboprost tromethamine, is subject to global manufacturing trends.

• India:

  • India is a major hub for API manufacturing due to its skilled workforce, cost-effectiveness, and established regulatory infrastructure.
  • Companies like Gland Pharma are prominent examples of Indian API suppliers.
  • India's domestic regulatory body, the Central Drugs Standard Control Organisation (CDSCO), aligns with international standards.

• United States and Europe:

  • While manufacturing has shifted in recent decades, some specialized API production, particularly for complex molecules or for supply to their respective domestic markets, remains in the U.S. and Europe.
  • Originator companies like AbbVie often maintain some level of in-house manufacturing in these regions.
  • These regions also house significant pharmaceutical R&D and advanced synthesis capabilities.

• China:

  • China is a dominant force in the global chemical and API supply chain, particularly for intermediates and less complex APIs.
  • While specific carboprost tromethamine API suppliers from China are less frequently disclosed in public pharmaceutical literature compared to Indian counterparts, Chinese chemical manufacturers are significant suppliers of the raw materials and earlier-stage intermediates used in its synthesis.

What market dynamics affect carboprost tromethamine supply?

The market for carboprost tromethamine is influenced by several factors common to niche pharmaceutical ingredients.

• Generic Competition:

  • The expiry of patents for branded Hemabate has led to the introduction of generic versions. This increases demand for carboprost tromethamine API from multiple manufacturers, including those producing generics.
  • Generic competition can drive down API pricing, putting pressure on suppliers to optimize manufacturing costs.

• Demand Fluctuations:

  • Demand for carboprost tromethamine is tied to obstetric practices and regional healthcare access. While essential, it is not a high-volume drug compared to treatments for chronic diseases.
  • Supply chain disruptions, such as those experienced during global health crises, can highlight vulnerabilities and lead to increased inventory holding by manufacturers.

• Regulatory Hurdles for New Entrants:

  • Establishing a new API manufacturing facility capable of producing carboprost tromethamine to pharmaceutical grade is capital-intensive and time-consuming due to rigorous regulatory approval processes.
  • This creates a barrier to entry and tends to consolidate the supplier base among established players.

• Supply Chain Resilience:

  • Recent global events have underscored the need for diversified and resilient supply chains. Pharmaceutical companies are increasingly seeking to qualify multiple suppliers for critical APIs and intermediates to mitigate risk.
  • This may lead to increased opportunities for well-qualified secondary or tertiary suppliers.

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Key Takeaways

• AbbVie Inc. is the primary internal supplier of carboprost tromethamine API for branded Hemabate.
• Gland Pharma Limited is a significant external supplier of carboprost tromethamine API, catering to generic manufacturers.
• The synthesis relies on specialized prostaglandin core structures and functionalized side chain precursors, sourced from fine chemical manufacturers. Tromethamine is widely available.
• Manufacturing operations are concentrated in India and, to a lesser extent, the U.S. and Europe, with China being a key supplier of earlier-stage intermediates.
• Adherence to GMP and regulatory filings (DMFs) is mandatory for all API suppliers.
• Market dynamics include generic competition and a growing emphasis on supply chain resilience, influencing supplier relationships and qualification processes.

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FAQs

1. What is the typical lead time for ordering pharmaceutical-grade carboprost tromethamine API? Lead times can vary significantly based on the supplier's current production schedule, order volume, and existing contractual commitments, often ranging from 3 to 9 months.

2. Are there any specific bioequivalence requirements for generic carboprost tromethamine products? Yes, generic carboprost tromethamine products must demonstrate bioequivalence to the reference listed drug (Hemabate), typically through pharmacokinetic studies, to gain regulatory approval.

3. What are the primary risks associated with the carboprost tromethamine supply chain? Key risks include reliance on a limited number of specialized API manufacturers, potential for single-source dependence for critical intermediates, geopolitical instability affecting key manufacturing regions, and stringent, evolving regulatory compliance demands.

4. How does the tromethamine counterion affect the stability and formulation of carboprost? Tromethamine forms a stable, water-soluble salt of carboprost, which is essential for its parenteral administration as an injectable solution. The salt form influences solubility, pH, and overall shelf-life of the finished drug product.

5. What differentiates a pharmaceutical-grade tromethamine supplier from a standard industrial supplier? Pharmaceutical-grade tromethamine suppliers must adhere to pharmacopoeial standards (e.g., USP, EP) for purity, impurity profiles, and heavy metals. They also require robust quality management systems, detailed Certificates of Analysis (CoA), and potentially GMP compliance depending on the specific regulatory pathway for the finished drug product.

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Citations

[1] AbbVie Inc. (n.d.). Hemabate Prescribing Information. Retrieved from [Relevant AbbVie/FDA website - specific link would be required if publicly available] [2] Gland Pharma Limited. (n.d.). Product Portfolio. Retrieved from [Relevant Gland Pharma website] [3] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from www.fda.gov [4] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from www.ema.europa.eu [5] BASF SE. (n.d.). Product Information: Tromethamine. Retrieved from [Relevant BASF website] [6] Merck KGaA. (n.d.). Sigma-Aldrich Product Catalog: Tromethamine. Retrieved from [Relevant MilliporeSigma website] [7] Ajinomoto Co., Inc. (n.d.). Chemical Products: Tromethamine. Retrieved from [Relevant Ajinomoto website]