Suppliers and packagers for generic pharmaceutical drug: DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	Camber Pharmaceuticals, Inc.	31722-052-01	100 CAPSULE in 1 BOTTLE (31722-052-01)	2024-07-01
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	Camber Pharmaceuticals, Inc.	31722-052-05	500 CAPSULE in 1 BOTTLE (31722-052-05)	2024-07-01
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	Camber Pharmaceuticals, Inc.	31722-052-10	1000 CAPSULE in 1 BOTTLE (31722-052-10)	2024-07-01
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	A-S Medication Solutions	50090-7729-0	30 CAPSULE in 1 BOTTLE (50090-7729-0)	2024-07-01
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	A-S Medication Solutions	50090-7729-2	60 CAPSULE in 1 BOTTLE (50090-7729-2)	2024-07-01
Annora Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	218018	ANDA	A-S Medication Solutions	50090-7729-8	90 CAPSULE in 1 BOTTLE (50090-7729-8)	2024-07-01

Dicyclomine Hydrochloride Drug Substance Suppliers Analysis

Last updated: February 19, 2026

This report identifies and analyzes key suppliers of Dicyclomine Hydrochloride drug substance. It examines production capacities, regulatory compliance, and potential supply chain risks, providing critical intelligence for pharmaceutical manufacturers and investors.

What is Dicyclomine Hydrochloride?

Dicyclomine Hydrochloride is an anticholinergic and antispasmodic medication. It is primarily used to relieve smooth muscle spasms in the gastrointestinal tract. This action makes it effective in treating symptoms associated with irritable bowel syndrome (IBS) and other gastrointestinal disorders, such as cramping, pain, and bloating. The mechanism of action involves blocking muscarinic acetylcholine receptors in the smooth muscle, preventing acetylcholine from binding and causing muscle contraction.

The drug substance, Dicyclomine Hydrochloride, is the active pharmaceutical ingredient (API) that manufacturers use to produce the final dosage forms, such as oral tablets, capsules, and injectable solutions. The quality and purity of the API are paramount to the efficacy and safety of the finished drug product.

Who are the Primary Manufacturers of Dicyclomine Hydrochloride API?

The global supply landscape for Dicyclomine Hydrochloride API is characterized by a mix of established API manufacturers and specialized chemical synthesis companies. Production is concentrated in regions with robust chemical manufacturing infrastructure, notably India and China, with some presence in Europe.

Key manufacturers include:

• Anatolia Pharmaceutical Pvt. Ltd.: This Indian-based company is a significant producer of generic APIs, including Dicyclomine Hydrochloride. They operate multiple manufacturing facilities and adhere to international quality standards.
• API Holding LLC (dba Paddock Laboratories LLC): While Paddock is primarily known as a finished dosage form manufacturer, they may also engage in backward integration or source API from specific, qualified partners. Their focus is on regulated markets, particularly the United States.
• Centaur Pharmaceuticals Pvt. Ltd.: Another Indian pharmaceutical company with a broad API portfolio. Centaur is known for its manufacturing capabilities and has a global reach for its products.
• Dishman Carbogen Amcis Ltd.: A Swiss-Indian company offering contract research and manufacturing services (CRAMS) for APIs. They possess advanced synthesis capabilities and cater to a global pharmaceutical clientele. Their involvement would likely be through custom synthesis or dedicated production campaigns.
• Hospira, Inc. (a Pfizer company): Hospira, prior to its acquisition by Pfizer, was a major player in injectable pharmaceuticals. Dicyclomine Hydrochloride is available as an injectable, and Hospira was a known supplier. Post-acquisition, this capacity is integrated within Pfizer's broader API manufacturing network.
• Laurus Labs Limited: A prominent Indian API manufacturer with a strong focus on complex chemistries and large-scale production. Laurus Labs has diversified its product basket and is a potential supplier for Dicyclomine Hydrochloride.
• Solara Active Pharma Sciences Limited: This Indian company specializes in the development and manufacturing of APIs. They have a significant presence in various therapeutic areas and are capable of producing Dicyclomine Hydrochloride.
• Taj Pharmaceuticals Ltd.: Based in India, Taj Pharmaceuticals manufactures a wide range of APIs and finished formulations. They are a significant exporter of pharmaceutical products and a potential source for Dicyclomine Hydrochloride.

This list is not exhaustive, as the API market is dynamic and includes numerous smaller or regionally focused manufacturers. The selection of a supplier is contingent on factors beyond just availability, including regulatory history, quality control, and pricing.

What are the Regulatory and Quality Standards for Dicyclomine Hydrochloride API?

The production of Dicyclomine Hydrochloride API for pharmaceutical use is strictly regulated to ensure patient safety and product efficacy. Manufacturers must comply with Good Manufacturing Practices (GMP) as defined by major regulatory bodies.

Key regulatory and quality considerations include:

• Current Good Manufacturing Practices (cGMP): Manufacturers must adhere to cGMP guidelines, which cover all aspects of production, including personnel, facilities, equipment, raw material sourcing, manufacturing processes, quality control, packaging, and labeling. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others audit facilities to ensure compliance.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory authorities (e.g., FDA in the US, or equivalent filings in other regions). A DMF provides confidential detailed information about the manufacturing, processing, packaging, and storing of the API. Pharmaceutical companies referencing a DMF in their drug product applications can gain access to this proprietary information, subject to the API manufacturer's authorization.
• Pharmacopoeial Standards: Dicyclomine Hydrochloride API must meet the specifications outlined in official pharmacopoeias. The primary pharmacopoeias include:
  • United States Pharmacopeia (USP): Defines identity, purity, assay, and other quality attributes for Dicyclomine Hydrochloride.
  • European Pharmacopoeia (Ph. Eur.): Similar to USP, this monograph sets standards for quality and testing.
  • British Pharmacopoeia (BP): Often aligns with USP and Ph. Eur.
  • Japanese Pharmacopoeia (JP): Sets standards for the Japanese market. Manufacturers must demonstrate that their API meets the requirements of the pharmacopoeia relevant to the target market.
• Impurity Profiling: Strict control over impurities, including related substances, residual solvents, and elemental impurities, is critical. Regulatory guidelines (e.g., ICH Q3A, Q3C, Q3D) dictate acceptable impurity limits. Manufacturers must validate their analytical methods for impurity detection and quantification.
• Stability Studies: API manufacturers must conduct comprehensive stability studies under various storage conditions (e.g., accelerated and long-term) to determine the re-test period or expiry date and recommend appropriate storage conditions.

Compliance with these standards is assessed through regular inspections and audits by regulatory agencies and by the pharmaceutical companies purchasing the API. A history of successful regulatory inspections and a robust quality management system are prerequisites for reliable API sourcing.

What are the Key Manufacturing Processes for Dicyclomine Hydrochloride?

The synthesis of Dicyclomine Hydrochloride involves multi-step organic chemical reactions. While specific proprietary processes may vary between manufacturers, the general synthetic route typically begins with readily available chemical precursors.

A common synthetic pathway involves:

1. Starting Materials: The synthesis often begins with a substituted cyclohexanecarboxylic acid derivative or a related precursor. For example, ethyl cyclohexanecarboxylate or cyclohexanecarboxylic acid.
2. Amidation: The carboxylic acid or ester is reacted with a suitable amine, such as diethylamine, to form an amide. This step introduces the diethylamino group characteristic of dicyclomine.
   • Example Reaction: Cyclohexanecarboxylic acid reacts with diethylamine in the presence of a coupling agent or under conditions that promote amide bond formation.
3. Alkylation: The resulting amide undergoes an alkylation reaction. This typically involves reaction with an alkyl halide, such as 3-chloropropane-1-ol or a related functionalized propyl halide. The purpose of this step is to introduce the third carbon chain which, after subsequent reactions, will bear the hydroxyl group and form the complete dicyclomine structure.
   • Example Reaction: N,N-diethylcyclohexanecarboxamide reacts with 3-chloropropane-1-ol under basic conditions to attach the hydroxypropyl chain to the nitrogen atom.
4. Hydrolysis (if ester intermediate is used): If an ester was used as a starting material, a hydrolysis step might be required to convert it to the carboxylic acid before amidation.
5. Salt Formation: The free base of Dicyclomine is then reacted with hydrochloric acid to form Dicyclomine Hydrochloride. This is typically done in a suitable solvent (e.g., isopropyl alcohol, ethanol) to precipitate the salt.
   • Example Reaction: Dicyclomine free base is dissolved in a solvent and treated with anhydrous hydrogen chloride gas or a solution of HCl in an organic solvent.
6. Purification: The crude Dicyclomine Hydrochloride is purified through crystallization, washing, and drying processes to meet pharmacopoeial standards for purity and impurity profiles. Techniques like recrystallization from appropriate solvent systems are crucial for removing residual starting materials, by-products, and solvents.

Process validation, optimization for yield, and robust impurity control are critical aspects of efficient and compliant manufacturing. Manufacturers invest in process development to improve efficiency, reduce waste, and ensure consistent product quality.

What are the Key Factors for Supplier Selection?

Selecting a reliable supplier for Dicyclomine Hydrochloride API involves a comprehensive evaluation of several critical factors. Pharmaceutical companies must balance cost, quality, regulatory compliance, and supply chain security.

Key selection criteria include:

• Quality and Regulatory Compliance:
  • cGMP Certification: Verified adherence to current Good Manufacturing Practices.
  • Regulatory Filings: Status and acceptance of the supplier's DMF or equivalent filings with relevant health authorities (FDA, EMA, etc.).
  • Inspection History: A record of successful inspections by regulatory bodies and customer audits.
  • Quality Management System (QMS): The robustness and effectiveness of the supplier's internal QMS, including change control, deviation management, and CAPA (Corrective and Preventive Actions).
• Technical Capabilities and Capacity:
  • Manufacturing Scale: Ability to produce API in required quantities with consistent quality.
  • Process Robustness: Demonstrated consistency in manufacturing processes and batch-to-batch reproducibility.
  • Analytical Capabilities: Well-equipped quality control laboratories with validated methods for API testing, including impurity analysis.
  • Technical Support: Availability of technical experts for troubleshooting and collaborative product development.
• Supply Chain Reliability and Security:
  • Lead Times: Predictable and reasonable lead times for API delivery.
  • Supply Chain Transparency: Understanding of the supplier's raw material sourcing and upstream supply chain.
  • Business Continuity Planning: The supplier's plans for mitigating disruptions (e.g., natural disasters, geopolitical events, raw material shortages).
  • Geographic Diversification: While less common for a single API, consider the supplier's manufacturing locations if multiple APIs are sourced.
• Cost and Commercial Terms:
  • Pricing: Competitive pricing that reflects the quality and service provided.
  • Payment Terms: Favorable payment terms.
  • Contractual Agreements: Clear and comprehensive supply agreements that define responsibilities, quality standards, and pricing.
• Auditing and Due Diligence:
  • On-site Audits: Regular audits of manufacturing facilities by the purchasing company.
  • Third-Party Audits: Utilizing third-party audit services for independent quality assessments.

For Dicyclomine Hydrochloride, which is an established generic API, price is often a significant factor. However, companies with a history of regulatory issues or quality lapses can incur substantial costs in the long run due to product recalls, regulatory enforcement actions, and supply disruptions. Therefore, a thorough risk assessment is essential.

What are the Potential Supply Chain Risks for Dicyclomine Hydrochloride?

The pharmaceutical supply chain for APIs, including Dicyclomine Hydrochloride, is susceptible to various risks that can impact availability, quality, and cost. Understanding these risks allows for proactive mitigation strategies.

Potential supply chain risks include:

• Raw Material Shortages: The synthesis of Dicyclomine Hydrochloride relies on specific chemical precursors. Disruptions in the supply of these raw materials, due to manufacturing issues at upstream suppliers, geopolitical events, or increased global demand, can lead to API production slowdowns or halts.
• Regulatory Non-Compliance: A supplier facing regulatory action (e.g., FDA warning letters, import alerts, EMA sanctions) due to GMP violations can lead to immediate cessation of supply to regulated markets. This forces pharmaceutical companies to find alternative, qualified suppliers, which is a time-consuming and costly process.
• Geopolitical Instability and Trade Restrictions: Concentration of API manufacturing in certain regions (e.g., India, China) makes the supply chain vulnerable to geopolitical tensions, trade disputes, tariffs, export controls, or local regulatory crackdowns that can impact manufacturing operations or the movement of goods.
• Natural Disasters and Environmental Incidents: Manufacturing facilities can be affected by earthquakes, floods, fires, or other environmental incidents, leading to temporary or permanent closure and significant supply disruptions.
• Quality Control Failures: Inconsistent quality control by a supplier can result in out-of-specification API batches, leading to rejection, investigations, and potential product recalls for finished drug products. This can also lead to loss of customer trust and business.
• Intellectual Property (IP) Issues: While Dicyclomine Hydrochloride is an established generic, there could be issues related to specific manufacturing processes or intermediates if not properly managed, though less likely for a mature product.
• Logistics and Transportation Disruptions: Issues with shipping, customs clearance, or freight availability can delay API deliveries, impacting manufacturing schedules for finished dosage forms.

Mitigation strategies include diversifying supplier bases where feasible, conducting thorough due diligence on supplier regulatory and quality histories, building buffer stock, and establishing strong contractual agreements with clear risk-sharing clauses. For established generic APIs like Dicyclomine Hydrochloride, having a second-source qualification process initiated before an actual shortage occurs is a prudent strategy.

Dicyclomine Hydrochloride Market Dynamics and Outlook

The market for Dicyclomine Hydrochloride API is primarily driven by the demand for generic finished dosage forms used to treat gastrointestinal disorders. As an off-patent drug, the market is competitive, with pricing being a significant factor.

Market dynamics:

• Generic Competition: The availability of multiple generic manufacturers for finished Dicyclomine Hydrochloride products intensifies competition and puts downward pressure on API pricing.
• Demand from Emerging Markets: Growing prevalence of IBS and other GI disorders in emerging economies contributes to the demand for affordable generic treatments, thus supporting API demand.
• Consolidation: The API manufacturing sector, particularly in India and China, has seen consolidation. This can impact supplier landscape and pricing power.
• Focus on Cost-Efficiency: API manufacturers continuously seek to optimize production processes to reduce costs, which is crucial for competitiveness in the generic market.
• Regulatory Scrutiny: Increased global regulatory scrutiny on API quality and manufacturing standards can lead to higher compliance costs for manufacturers but also serves to weed out less compliant suppliers, potentially stabilizing the market for high-quality providers.

Outlook:

The outlook for Dicyclomine Hydrochloride API remains stable, tied to the ongoing demand for generic antispasmodic medications. While no significant new therapeutic breakthroughs are anticipated to drastically alter its use, the consistent need for treatment of functional GI disorders will sustain its market. Manufacturers will likely continue to focus on cost-effective production and maintaining robust quality systems to remain competitive. Suppliers with strong regulatory track records and efficient supply chains will be best positioned.

Key Takeaways

• Dicyclomine Hydrochloride API manufacturing is dominated by companies in India and China, with established players like Anatolia Pharmaceutical, Laurus Labs, and Solara Active Pharma Sciences being key producers.
• Stringent adherence to cGMP, pharmacopoeial standards (USP, Ph. Eur.), and robust impurity profiling are critical for API suppliers. Regulatory filings like DMFs are essential for market access in regulated regions.
• The synthesis involves multi-step organic chemistry, typically culminating in salt formation with hydrochloric acid and subsequent purification.
• Supplier selection hinges on a comprehensive evaluation of quality, regulatory compliance, manufacturing capacity, supply chain reliability, and cost.
• Potential supply chain risks include raw material shortages, regulatory non-compliance, geopolitical instability, and quality control failures.
• The market for Dicyclomine Hydrochloride API is driven by generic finished dosage forms, characterized by price competition and stable demand for gastrointestinal treatments.

Frequently Asked Questions

What is the typical purity requirement for Dicyclomine Hydrochloride API according to pharmacopoeias?

Pharmacopoeias such as the USP and Ph. Eur. typically specify a purity requirement of not less than 98.5% and not more than 101.0% of Dicyclomine Hydrochloride, calculated on the dried basis. This range accounts for assay variability and potential moisture content.

How are residual solvents controlled in Dicyclomine Hydrochloride API manufacturing?

Residual solvents are controlled by selecting appropriate solvents for synthesis and purification steps, employing efficient drying techniques, and validating analytical methods to quantify their presence. ICH Q3C guidelines classify solvents into three classes based on their toxicity and establish acceptable limits for each.

Can a single API manufacturer supply Dicyclomine Hydrochloride for both the US and European markets?

Yes, a single API manufacturer can supply Dicyclomine Hydrochloride for both the US and European markets, provided they have obtained the necessary regulatory approvals. This typically involves having a DMF accepted by the FDA and an ASMF (Active Substance Master File) or equivalent filing accepted by the EMA or national competent authorities in EU member states.

What is the typical re-test period for Dicyclomine Hydrochloride API?

The re-test period for Dicyclomine Hydrochloride API can vary depending on the manufacturer's stability studies and packaging. However, it commonly ranges from 2 to 5 years when stored under recommended conditions, typically in well-closed containers protected from light and moisture.

What are the primary applications of Dicyclomine Hydrochloride beyond IBS?

Beyond Irritable Bowel Syndrome (IBS), Dicyclomine Hydrochloride is also prescribed to treat symptoms of other gastrointestinal disorders characterized by smooth muscle spasms, such as infantile colic, biliary colic, renal colic, and muscle spasms of the uterus. It is used symptomatically to relieve pain and discomfort.

Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). Author.

[2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia (Ph. Eur.). Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1995). Impurities: Guideline for Residual Solvents, Q3C(R4).

[4] Food and Drug Administration. (2009). Guidance for Industry: ANDAs – CMC Issues.

[5] U.S. Food and Drug Administration. (2023). Guidance for Industry: Drug Master Files. Retrieved from https://www.fda.gov/drugs/drug-master-file/guidance-industry-drug-master-files