Gabapentin 60142-96-3 Manufacturer Exporter MEDIOCON INC

 

Gabapentin Manufactured by MEDIOCON INC     

 

·   Name: Gabapentin

 

·   CAS No: 60142-96-3

 

 

·   Molecular Weight: 171.23g/mol

 

·   Molecular formula:   C₉H₁₇NO₂

 

 

·   Synonyms:  Neurontin, Gralise, and Horizant.

                                                

·   Appearance:  white to off-white powder

 

 

·   Solubility :   soluble in water.

 

·   Use :

Gabapentin is used for:

1. Seizure control: Adjunctive treatment for partial seizures.

2. Nerve pain: Relief of neuropathic pain, such as diabetic neuropathy or postherpetic neuralgia.

3. Other conditions: Sometimes prescribed off-label for anxiety, insomnia, or restless leg syndrome.

 

Gabapentin works by affecting neurotransmitters in the brain. Consult a healthcare professional for personalized guidance on using gabapentin.

 

·      How is  Gabapentin  manufactured by MEDIOCON INC Synthesized?

 

Gabapentin synthesis involves a multi-step chemical process:

 

1. Starting material: Cyclohexanone or other suitable precursors.

2. Chemical reactions: Series of reactions, including condensation, reduction, and purification steps.

3. Final product: Gabapentin is obtained through crystallization and purification.

 

The exact synthesis method may vary depending on the manufacturer. Gabapentin's chemical structure is designed to mimic the neurotransmitter GABA, but it doesn't directly interact with GABA receptors.

 

·         What are the different  dosage forms  of   Gabapentin  Manufactured  by  MEDIOCON INC?

 

Gabapentin is available in several dosage forms:

 

1. Capsules: 100mg, 300mg, and 400mg strengths.

2. Tablets: 600mg and 800mg strengths.

3. Oral Solution: Liquid formulation, typically 250mg/5mL.

 

These dosage forms offer flexibility for patients with different needs. Consult a healthcare professional for guidance on the most suitable form and dosage.

 

·         How Gabapentin  Manufactured by MEDIOCON INC   Dosage Forms are prepared?

 

Gabapentin dosage forms are prepared through various pharmaceutical processes:

 

Capsules:

 

1. Mixing gabapentin powder with excipients.

2. Filling capsule shells.

3. Quality control checks.

 

Tablets:

 

1. Granulation or direct compression.

2. Blending gabapentin with binders and fillers.

3. Compressing into tablets.

4. Coating (if necessary).

 

Oral Solution:

 

1. Dissolving gabapentin in a suitable solvent.

2. Adding flavorings and preservatives.

3. Filtration and quality control.

 

Manufacturers follow strict guidelines to ensure product quality, efficacy, and safety.

 

 

 

·         What are the appropriate Dosage forms of Gabapentin  Manufactured  by  MEDIOCON   INC?

Appropriate dosage forms of Gabapentin include:

 

1. Capsules: Suitable for oral administration.

2. Tablets: Convenient for patients who prefer solid dosage forms.

3. Oral Solution: Ideal for patients with swallowing difficulties or variable dosing needs.

 

The choice of dosage form depends on individual patient needs, preferences, and medical conditions. Consult a healthcare professional for personalized guidance.

 

·         When should Gabapentin  Manufactured by MEDIOCON INC be taken?

Gabapentin is typically taken:

 

1. With or without food: As directed by the healthcare provider.

2. At consistent times: To maintain steady medication levels.

3. As prescribed: Follow the recommended dosage and schedule.

 

It's essential to follow the healthcare provider's instructions for optimal effectiveness and minimal side effects.

 

·         What are the effects And Side effects of  Gabapentin  Manufactured by MEDIOCON INC?

Effects of Gabapentin:

 

1. Seizure control: Reduces frequency of seizures.

2. Nerve pain relief: Alleviates neuropathic pain.

3. Anxiolytic effects: May help with anxiety.

 

Common Side Effects:

 

1. Dizziness

2. Drowsiness

3. Fatigue

4. Headache

5. Nausea

 

Less Common Side Effects:

1. Weight gain

2. Mood changes

3. Memory problems

4. Coordination issues

Rare but Serious Side Effects:

1. Allergic reactions

2. Respiratory depression (rare)

Consult a healthcare professional for personalized guidance and monitoring.

 

·         How is Gabapentin  Manufactured by MEDIOCON  INC  Tested Qualitatively?

Gabapentin is qualitatively tested using various analytical techniques, including:

 

1. High-Performance Liquid Chromatography (HPLC): Separates and identifies gabapentin.

2. Gas Chromatography (GC): Analyzes gabapentin's chemical composition.

3. Mass Spectrometry (MS): Confirms gabapentin's molecular structure.

4. Infrared Spectroscopy (IR): Identifies gabapentin's functional groups.

 

These tests ensure gabapentin's identity, purity, and quality.

 

·         Which tests are performed on Gabapentin  Manufactured by  MEDIOCON INC ?

Several tests are performed on Gabapentin to ensure its quality, purity, and potency:

 

1. Identification tests: Confirm gabapentin's presence.

2. Purity tests: Detect impurities.

3. Assay tests: Determine gabapentin's potency.

4. Dissolution tests: Evaluate gabapentin's release rate.

 

Common analytical techniques include:

 

1. HPLC (High-Performance Liquid Chromatography)

2. GC (Gas Chromatography)

3. MS (Mass Spectrometry)

4. IR (Infrared Spectroscopy)

 

These tests help ensure gabapentin's safety and efficacy.

 

 

·         What are the challenges in Manufacturing of Gabapentin  Manufactured by MEDIOCON   INC API?

Challenges in manufacturing Gabapentin API (Active Pharmaceutical Ingredient) include:

 

1. Synthesis complexity: Gabapentin's synthesis involves multiple steps.

2. Impurity control: Managing impurities is crucial for API quality.

3. Crystallinity: Controlling crystal form and polymorphism.

4. Scalability: Scaling up production while maintaining quality.

5. Regulatory compliance: Meeting stringent regulatory requirements.

 

Manufacturers must optimize processes, monitor quality, and adhere to regulations to ensure API quality and consistency.

 

·         What are the challenges in manufacturing of Gabapentin  Manufactured by MEDIOCON  INC ’s Dosage forms?

Challenges in manufacturing Gabapentin dosage forms include:

 

1. Uniformity and content control: Ensuring consistent gabapentin content.

2. Stability: Maintaining physical and chemical stability.

3. Bioavailability: Ensuring gabapentin is released and absorbed effectively.

4. Regulatory compliance: Meeting FDA and other regulatory requirements.

5. Scale-up and process optimization: Scaling production while maintaining quality.

 

Manufacturers must optimize formulations, processes, and quality control to ensure dosage form efficacy, safety, and consistency.

 

·         What is the Packing for Gabapentin  Manufactured by MEDIOCON INC?

Gabapentin packaging typically includes:

 

1. Bottles: HDPE (High-Density Polyethylene) or glass bottles.

2. Blister packs: Unit-dose or multi-dose packaging.

3. Capsule or tablet containers: Secure, child-resistant closures.

 

Packaging materials are chosen to:

 

1. Protect gabapentin from moisture, light, and air.

2. Ensure product stability and potency.

3. Comply with regulatory requirements.

 

Labeling includes essential information, such as dosage instructions, warnings, and storage conditions.

 

 

 

 

 

·         What is shelf life Of Gabapentin  Manufactured by MEDIOCON INC? 

The shelf life of Gabapentin varies depending on the formulation and storage conditions. Typically:

1. Capsules and tablets: 2-5 years from manufacturing date.

2. Oral solution: Usually 2-3 years, but check specific product labeling.

Storage conditions, such as temperature, humidity, and light exposure, can impact shelf life. Always check the expiration date and follow storage instructions.

 

 

·         What should the label claim for Gabapentin  Manufactured by MEDIOCON INC   Include?

The label claim for Gabapentin should include:

 

1. Active ingredient: Gabapentin

2. Strength: Dosage strength (e.g., 100mg, 300mg)

3. Dosage form: Capsule, tablet, or oral solution

4. Directions: Dosage instructions

5. Warnings and precautions: Potential side effects, contraindications

6. Storage conditions: Temperature, humidity, and light exposure guidelines

7. Expiration date: Manufacturing date and expiration date

8. Manufacturer information: Name and contact details

 

Accurate labeling ensures safe and effective use.

 

·         Where can Gabapentin  Manufactured by MEDIOCON INC are procured?

Gabapentin Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

1.      FOR API

 MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

 GST No: 27DHUPM2366D1ZZ

 

2.      For Dosage Forms :

     - Online Marketplaces: You can find Gabapentin Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

 - Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Gabapentin Manufactured by MEDIOCON INC products.

 Remember to ensure the quality and authenticity of the Gabapentin Manufactured by MEDIOCON INC product, regardless of the procurement source.