Citalopram API Manufacturer & Bulk Supplier in India | Swapnroop Drugs & Pharmaceuticals

Introduction to Citalopram API

Citalopram API is an important pharmaceutical active ingredient belonging to the selective serotonin reuptake inhibitor (SSRI) class of antidepressant medicines. It is widely used in pharmaceutical formulations developed for the treatment of major depressive disorder and other approved mental health conditions.

Citalopram works by inhibiting the reuptake of serotonin (5-hydroxytryptamine or 5-HT) into presynaptic neurons. This increases the availability of serotonin in the synaptic space and enhances serotonergic neurotransmission within the central nervous system.

The API is commonly supplied in the form of citalopram hydrobromide, which is used in the manufacture of oral pharmaceutical dosage forms, including tablets and oral solutions.

Citalopram has an established position in the pharmaceutical industry because of its well-characterized pharmacological properties, established clinical applications, and availability in different oral formulations.

For pharmaceutical manufacturers, formulation developers, API distributors, and procurement professionals, Citalopram API represents an important ingredient within the central nervous system (CNS) and antidepressant pharmaceutical segments.

Swapnroop Drugs & Pharmaceuticals focuses on pharmaceutical raw materials and API-related business enquiries, supporting professional customers seeking product information, technical specifications, and sourcing assistance.

What Is Citalopram API?

Citalopram is a racemic bicyclic phthalane derivative classified as a selective serotonin reuptake inhibitor.

It contains two enantiomers, R-citalopram and S-citalopram. The S-enantiomer is known as escitalopram and is responsible for most of the serotonin reuptake inhibitory activity.

Citalopram hydrobromide is the commonly used pharmaceutical salt form. It is a white to off-white powder and is used in the production of oral antidepressant medicines.

Its primary approved therapeutic application is the treatment of major depressive disorder in adults, subject to the applicable product authorization and prescribing information.

Key Product Information

• Product Name: Citalopram

• Alternative Name: Citalopram Hydrobromide

• Chemical Class: Bicyclic phthalane derivative

• Pharmacological Class: Selective Serotonin Reuptake Inhibitor (SSRI)

• CAS Number (Free Base): 59729-33-8

• CAS Number (Hydrobromide): 59729-32-7

• Molecular Formula (Free Base): C20H21FN2O

• Molecular Weight (Free Base): 324.39 g/mol

• Molecular Formula (Hydrobromide): C20H22BrFN2O

• Molecular Weight (Hydrobromide): 405.35 g/mol

• Physical Appearance (Hydrobromide): Fine white to off-white powder

• Solubility: Sparingly soluble in water and soluble in ethanol

• Therapeutic Category: Antidepressant

• Primary Pharmaceutical Application: Major Depressive Disorder

Note: The free base and hydrobromide salt have different molecular formulas, molecular weights, and CAS numbers. Confirm the exact chemical form and applicable pharmacopoeial grade before procurement.

Chemical Structure and Properties of Citalopram

Citalopram has a distinctive bicyclic phthalane structure containing a fluorophenyl group, a nitrile functional group, and a dimethylaminopropyl side chain.

These structural features contribute to its physicochemical properties and pharmacological activity.

The molecule is available as a racemic mixture containing two enantiomers.

Important chemical characteristics include:

• Bicyclic phthalane molecular framework.

• Fluorophenyl substituent.

• Nitrile functional group.

• Tertiary amine side chain.

• Two optical enantiomers.

• Hydrobromide salt form used in pharmaceutical formulations.

Citalopram hydrobromide is commonly evaluated for identity, assay, related substances, residual solvents, and other relevant quality parameters.

Mechanism of Action of Citalopram

Citalopram works primarily by inhibiting the serotonin transporter (SERT), which is responsible for removing serotonin from the synaptic space and transporting it back into presynaptic neurons.

Serotonin is a neurotransmitter involved in several physiological processes, including:

• Mood regulation.

• Emotional responses.

• Sleep.

• Appetite.

• Cognitive functions.

• Stress-related responses.

Citalopram selectively inhibits serotonin reuptake and has comparatively minimal effects on norepinephrine and dopamine reuptake.

Its mechanism can be understood through the following stages.

1. Serotonin Transporter Interaction

Citalopram interacts with the serotonin transporter located on presynaptic neurons.

2. Inhibition of Serotonin Reuptake

It reduces the reuptake of serotonin from the synaptic space into presynaptic nerve cells.

3. Increased Serotonin Availability

This increases extracellular serotonin availability and enhances serotonergic neurotransmission.

4. Antidepressant Pharmacological Effect

The resulting changes in serotonergic signaling contribute to its antidepressant therapeutic activity.

The complete mechanism responsible for antidepressant effects is not fully understood. Clinical improvement may take several weeks.

Pharmaceutical Applications of Citalopram API

Citalopram is primarily used in pharmaceutical products designed for the treatment of major depressive disorder.

Its pharmacological characteristics make it an important ingredient within the antidepressant pharmaceutical category.

1. Major Depressive Disorder

Citalopram is approved for the treatment of major depressive disorder in adults in the United States.

It works by increasing serotonergic neurotransmission through inhibition of serotonin reuptake.

2. Depression-Related Pharmaceutical Research

Citalopram is relevant to pharmaceutical research involving serotonin signaling, antidepressant mechanisms, and selective serotonin reuptake inhibition.

3. CNS Drug Development

Its established pharmacological profile makes it useful in research and development involving central nervous system medicines.

4. Oral Pharmaceutical Formulation Development

Citalopram hydrobromide is used in the development of different oral dosage forms, including tablets and oral solutions.

Formulation research may involve excipient compatibility, dissolution characteristics, stability, and pharmaceutical performance.

Different Pharmaceutical Formulations of Citalopram

Citalopram API is commonly incorporated into oral pharmaceutical formulations.

1. Citalopram Tablets

Citalopram tablets are available in different strengths according to approved product specifications.

Common marketed strengths include 10 mg, 20 mg, and 40 mg, expressed as citalopram base equivalent.

The actual quantity of citalopram hydrobromide required is higher because the salt has a greater molecular weight than the free base.

2. Citalopram Oral Solution

Citalopram is also available in oral solution formulations.

These products provide an alternative oral dosage form for patients who require a liquid preparation.

3. Film-Coated Tablets

Film-coated formulations are developed using appropriate pharmaceutical excipients to support product stability, appearance, and handling.

4. Generic Pharmaceutical Formulations

Citalopram is used in generic pharmaceutical product development, subject to applicable regulatory requirements and product specifications.

Manufacturing and Quality Considerations for Citalopram API

The manufacturing of Citalopram API requires controlled chemical processing, appropriate impurity management, and validated analytical quality-control procedures.

For citalopram hydrobromide, additional attention is required to ensure the correct salt formation and consistent product quality.

Important manufacturing considerations include:

1. Raw Material Quality

Starting materials and manufacturing inputs should meet defined quality requirements.

2. Chemical Identity

The identity of citalopram should be confirmed using appropriate analytical techniques.

3. Salt Formation

For citalopram hydrobromide, the salt formation process should be controlled to achieve the required chemical composition and product characteristics.

4. Assay and Purity

The API should meet the applicable assay and purity requirements.

5. Impurity Management

Process-related impurities and degradation products should be monitored through validated analytical methods.

6. Enantiomeric Composition

Because citalopram is a racemic mixture, the enantiomeric composition should be appropriately controlled according to the applicable specification.

7. Stability Testing

Stability studies help establish suitable storage conditions, packaging requirements, and retest periods.

8. Packaging and Storage

The finished API should be packed in appropriate pharmaceutical-grade containers to protect it against contamination and unsuitable environmental conditions.

Quality Control and Testing of Citalopram API

Quality control is an essential part of pharmaceutical API manufacturing and procurement.

The following parameters may be evaluated according to the applicable pharmacopoeial monograph and approved product specification.

1. Identification Testing

Identity testing confirms that the material corresponds to citalopram hydrobromide.

Suitable methods may include infrared spectroscopy and chromatographic identification.

2. Assay

Assay testing determines the active ingredient content using an appropriate validated analytical procedure.

The calculation basis should be clearly defined as citalopram hydrobromide or citalopram base equivalent.

3. Related Substances

Related-substance testing evaluates process-related impurities and degradation products.

4. Enantiomeric Purity

Chiral analytical methods may be used to evaluate the relative proportions of R-citalopram and S-citalopram where required.

5. Residual Solvents

Residual solvent levels should comply with applicable pharmaceutical requirements.

6. Water Content

Water content may be evaluated according to the applicable product specification.

7. Appearance and Solubility

The physical appearance and relevant solubility properties should be assessed against established specifications.

8. Stability Testing

Stability studies evaluate changes in API quality under defined storage conditions.

Actual numerical limits should be obtained from the applicable approved specification or pharmacopoeial monograph rather than assumed.

Pharmaceutical Documentation Required for Citalopram API

Pharmaceutical manufacturers and API procurement professionals should request relevant documentation before purchasing Citalopram API.

Depending on the intended pharmaceutical application and destination market, the documentation package may include:

1. Certificate of Analysis (COA).

2. Technical Data Sheet (TDS).

3. Safety Data Sheet (SDS).

4. Product Specification Sheet.

5. Identification and Assay Reports.

6. Related Substances Report.

7. Residual Solvent Report.

8. Chiral Purity Information, where applicable.

9. Stability Study Information.

10. Manufacturing and GMP Documentation.

11. Batch Traceability Records.

12. Applicable Pharmacopoeial Compliance Documents.

The exact documentation should be verified for the chemical form and grade being supplied.

Regulatory Considerations for Citalopram API in India

Citalopram is a prescription antidepressant pharmaceutical ingredient.

Its manufacturing, testing, distribution, and commercial supply must comply with applicable Indian pharmaceutical regulatory requirements.

Important regulatory considerations include:

• Applicable drug manufacturing licences.

• Good Manufacturing Practices (GMP).

• Pharmacopoeial quality standards.

• Approved manufacturing processes.

• Analytical method validation.

• Impurity and degradation product controls.

• Batch manufacturing records.

• Packaging and labelling requirements.

• Import and export permissions, where applicable.

• Regulatory documentation for the destination market.

Manufacturers should also consider applicable requirements for the development and registration of finished antidepressant formulations.

Why Quality Matters When Sourcing Citalopram API

Quality is an important consideration when sourcing pharmaceutical ingredients for antidepressant formulations.

Pharmaceutical manufacturers should evaluate several parameters before selecting an API supplier.

Verified Chemical Identity: Confirm that the material is citalopram hydrobromide or the specifically required chemical form.

Consistent Assay: Ensure that the API meets the agreed potency requirements.

Impurity Control: Evaluate related substances and degradation products.

Enantiomeric Composition: Confirm the required racemic composition or other specified stereochemical characteristics.

Pharmacopoeial Compliance: Verify compliance with the applicable IP, BP, USP, or other required standard.

Analytical Documentation: Review the batch-specific Certificate of Analysis and supporting test reports.

Manufacturing Quality: Evaluate the supplier's quality systems and applicable GMP documentation.

Batch Traceability: Ensure that manufacturing and quality records are appropriately maintained.

Citalopram API Bulk Procurement and Pharmaceutical Supply

Bulk procurement of Citalopram API involves coordination between pharmaceutical manufacturers, generic formulation companies, distributors, and procurement departments.

Before purchasing, buyers should evaluate the intended dosage form, required chemical form, applicable specifications, and regulatory documentation.

Important procurement considerations include:

• Required chemical form.

• Required pharmacopoeial grade.

• API assay and purity specifications.

• Enantiomeric composition.

• Related-substance profile.

• Batch-specific Certificate of Analysis.

• Packaging and storage requirements.

• Manufacturing source.

• Regulatory documentation.

• Delivery and supply-chain arrangements.

A qualified supplier should provide accurate product information and appropriate quality documentation for the intended pharmaceutical application.

Why Choose Swapnroop Drugs & Pharmaceuticals for API Sourcing?

Swapnroop Drugs & Pharmaceuticals focuses on pharmaceutical raw materials and API-related business enquiries.

We understand the importance of product quality, technical information, regulatory suitability, and professional communication in pharmaceutical procurement.

Our business approach emphasizes:

• Pharmaceutical product information.

• API and raw material sourcing enquiries.

• Product specification discussions.

• Quality documentation coordination.

• Professional B2B communication.

• Domestic and international business enquiries.

• Customer-focused pharmaceutical sourcing assistance.

For Citalopram API enquiries, buyers can contact Swapnroop Drugs & Pharmaceuticals to discuss applicable grades, product specifications, documentation, and commercial sourcing requirements.

Product availability, manufacturing origin, and supply capability should be confirmed directly before any purchase commitment.

Future Outlook of Citalopram in the Pharmaceutical Industry

Antidepressant medicines continue to represent an important segment of the pharmaceutical industry.

Citalopram remains an established SSRI with applications in the treatment of major depressive disorder.

The pharmaceutical industry continues to focus on improving the quality, stability, manufacturing efficiency, and regulatory compliance of generic antidepressant formulations.

Research involving serotonin transporters, antidepressant pharmacology, and CNS drug development also continues to contribute to scientific understanding of this therapeutic category.

For pharmaceutical manufacturers and API suppliers, Citalopram remains a relevant ingredient within the antidepressant and central nervous system pharmaceutical market.

Frequently Asked Questions (FAQs) About Citalopram API

1. What is Citalopram API?

Citalopram API is a selective serotonin reuptake inhibitor used in pharmaceutical formulations for the treatment of major depressive disorder.

2. What is the CAS number of Citalopram?

The CAS number of citalopram free base is 59729-33-8. Citalopram hydrobromide has CAS number 59729-32-7.

3. What is the molecular formula of Citalopram?

The molecular formula of citalopram free base is C20H21FN2O.

4. What is the molecular formula of Citalopram Hydrobromide?

The molecular formula of citalopram hydrobromide is C20H22BrFN2O.

5. What is the molecular weight of Citalopram Hydrobromide?

Citalopram hydrobromide has a molecular weight of approximately 405.35 g/mol.

6. What is the mechanism of action of Citalopram?

Citalopram selectively inhibits serotonin reuptake by interacting with the serotonin transporter, increasing serotonin availability in the synaptic space.

7. What is the pharmaceutical classification of Citalopram?

Citalopram belongs to the selective serotonin reuptake inhibitor (SSRI) class of antidepressants.

8. What are the pharmaceutical applications of Citalopram?

Its primary approved application is the treatment of major depressive disorder in adults. Other uses depend on the relevant country's regulatory approval and clinical guidance.

9. What is the difference between Citalopram and Escitalopram?

Citalopram is a racemic mixture containing R- and S-enantiomers. Escitalopram is the S-enantiomer of citalopram.

10. What quality tests are important for Citalopram API?

Important tests may include identification, assay, related substances, residual solvents, water content, and enantiomeric purity where required.

11. What documents should buyers request for Citalopram API?

Buyers should request a Certificate of Analysis, specification sheet, SDS, analytical reports, stability information, and applicable GMP and pharmacopoeial documentation.

12. Who can enquire about Citalopram API?

Pharmaceutical manufacturers, generic formulation companies, API distributors, and qualified pharmaceutical procurement organizations can enquire about Citalopram API for legitimate pharmaceutical manufacturing requirements.

Conclusion

Citalopram is an established selective serotonin reuptake inhibitor with important applications in the pharmaceutical treatment of major depressive disorder.

Its ability to inhibit serotonin reuptake, established chemical characteristics, and availability in different oral formulations make it an important ingredient within the antidepressant pharmaceutical segment.

For pharmaceutical manufacturers and procurement professionals, sourcing Citalopram API requires careful evaluation of chemical identity, salt form, assay, purity, enantiomeric composition, impurity profile, and pharmacopoeial compliance.

Swapnroop Drugs & Pharmaceuticals welcomes professional pharmaceutical API and raw material enquiries.

Contact our team to discuss Citalopram API product information, technical specifications, quality documentation, and bulk procurement requirements.

Swapnroop Drugs & Pharmaceuticals – Your Partner for Pharmaceutical API and Raw Material Sourcing.