Baclofen Extended-Release (GRS) Capsules 40mg

Baclofen Extended-Release (GRS) Capsules 40mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Baclofen Extended-Release (GRS) Capsules IP 10mg
B) Baclofen Extended-Release (GRS) Capsules IP 20mg
C) Baclofen Extended-Release (GRS) Capsules IP 30mg
D) Baclofen Extended-Release (GRS) Capsules IP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Baclofen Extended-Release (GRS) Capsules IP 10mg
Each uncoated extended-Release (GRS) capsule contains:
Baclofen IP……………………10mg
Excipients………………………q.s.
Approved colours used in capsule shells.

B) Baclofen Extended-Release (GRS) Capsules IP 20mg
Each extended-Release (GRS) capsule contains:
Baclofen IP……………………20mg
Excipients………………………q.s.
Approved colours used in capsule shells.

C) Baclofen Extended-Release (GRS) Capsules IP 30mg
Each extended-Release (GRS) capsule contains:
Baclofen IP…………………….30mg
Excipients……………………….q.s.
Approved colours used in capsule shells.

D) Baclofen Extended-Release (GRS) Capsules IP 40mg
Each extended-Release (GRS) Capsule contains:
Baclofen IP……………………..40mg
Excipients………………………..q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Baclofen is a muscle relaxer and an antispasmodic agent.
Baclofen is used to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
This medicine should be taken in the morning after food or after the main meal of the day.

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.

Introduction to Baclofen Extended-Release (GRS) Capsules 40mg

Baclofen Extended-Release (GRS) Capsules 40mg is a widely prescribed skeletal muscle relaxant primarily used for the management of muscle spasms, stiffness, and pain associated with multiple sclerosis, spinal cord conditions, and neurological disorders. As an extended-release formulation, it ensures sustained therapeutic effect throughout the day, reducing the need for multiple doses and improving patient compliance.

This medication works by acting on the central nervous system, targeting the spinal cord nerves to decrease the frequency and severity of muscle spasms. Additionally, clinical studies have shown that Baclofen ER improves total sleep time, enhances REM and non-REM sleep duration, and reduces nighttime awakenings, making it an essential therapy for patients suffering from chronic muscle spasticity.

Globally, the demand for Baclofen Extended-Release (GRS) Capsules 40mg is growing due to increasing incidences of neurological conditions, multiple sclerosis, and spinal cord injuries, particularly in the USA, Europe, Middle East, and Asia-Pacific markets.

Details for Importers, Exporters, and Buyers

International buyers require complete transparency, regulatory compliance, and flexibility in packaging when sourcing pharmaceuticals from India. Taj Pharma ensures comprehensive support for global procurement of Baclofen ER Capsules 40mg.

1. Regulatory Documentation Provided

Taj Pharma supplies all essential dossiers and certifications, including:

• WHO-GMP Certificate

• EU-GMP Approval

• Certificate of Pharmaceutical Product (COPP)

• Common Technical Document (CTD) Dossier

• Free Sale Certificate

• Stability Data (Zone-wise)

• Regulatory Support for product registration

2. Custom Packaging & Labeling

• Primary & secondary packaging tailored to buyer’s requirements

• Multilingual labeling compliant with country-specific regulations

• Blister packs, HDPE bottles, or customized export cartons

• Barcoding and serialization as per USFDA/EMA compliance

3. Shelf-life, Storage, Dosage Form

• Dosage Form: Capsules (Extended-Release)

• Strength: 40mg

• Shelf-life: 24–36 months

• Storage: Store below 30°C, protected from moisture and light

4. Export Certifications

Taj Pharma Baclofen ER Capsules 40mg are backed by internationally recognized certifications:

• WHO-GMP

• EU-GMP

• ISO 9001:2015

• COPP for global exports

• FDA & EMA-compliant manufacturing standards

5. Target Countries & Export Markets

Taj Pharma has strong export markets across North America, Latin America, Europe, Africa, CIS, Middle East, and Asia-Pacific. Key import countries include:

• USA, UK, Germany, France, Italy

• UAE, Saudi Arabia, Qatar, Kuwait

• South Africa, Nigeria, Kenya, Ghana

• Russia, Ukraine, Kazakhstan

• Sri Lanka, Vietnam, Philippines

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

Taj Pharma stands out as the #1 Baclofen Extended-Release (GRS) Capsules 40mg manufacturer in India due to its strong commitment to quality, affordability, and reliability.

1. State-of-the-Art Manufacturing

• WHO-GMP, EU-GMP, and ISO-certified units in Vapi, Gujarat

• Fully automated production lines ensuring zero contamination

• Advanced R&D facilities for formulation development

2. Affordable Pricing & Quality Assurance

• Competitive pricing for bulk buyers and PCD franchise partners

• Stringent quality control checks at every stage

• Adherence to ICH, WHO, and pharmacopeial standards

3. Global Presence & Supply Chain Support

• Exporting to over 80 countries worldwide

• Robust logistics ensuring timely deliveries

• Strategic tie-ups with global distributors

4. Top 20 Countries Exporting

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

If you are a pharmaceutical distributor, importer, or healthcare provider looking for a reliable source of Baclofen Extended-Release (GRS) Capsules 40mg, Taj Pharma is your trusted partner.

With world-class manufacturing, regulatory expertise, and strong export capabilities, Taj Pharma ensures seamless supply chain support worldwide.

👉 Contact us today at Taj Pharma Official Website to get the best prices and regulatory support for your market.

Top 20 FAQs 

Q1. What are Baclofen Extended-Release (GRS) Capsules 40mg used for?
A: They treat muscle spasms and stiffness in patients with multiple sclerosis or spinal cord disorders.

Q2. Is Baclofen ER safe for long-term use?
A: Yes, but doses should be tapered gradually under medical supervision.

Q3. Does Taj Pharma manufacture Baclofen ER Capsules 40mg in India?
A: Yes, Taj Pharma is a WHO-GMP certified manufacturer in Vapi, Gujarat.

Q4. Can Baclofen ER cause drowsiness?
A: Yes, common side effects include sleepiness, dizziness, and weakness.

Q5. What certifications does Taj Pharma hold?
A: WHO-GMP, EU-GMP, ISO 9001:2015, COPP, and CTD dossier support.

Q6. How should Baclofen ER be stored?
A: Store below 30°C, protected from light and moisture.

Q7. Can importers request custom labeling?
A: Yes, Taj Pharma provides country-specific packaging and labeling.

Q8. What is the shelf-life of Baclofen ER Capsules?
A: 24–36 months.

Q9. Does Taj Pharma export globally?
A: Yes, to over 80 countries worldwide.

Q10. Can Baclofen ER improve sleep quality?
A: Yes, studies show improved REM and non-REM sleep.

Q11. Is Baclofen ER available in generic form?
A: Yes, Taj Pharma manufactures generic Baclofen ER.

Q12. Can Baclofen ER be used for back pain?
A: It is prescribed for muscle spasms, not general back pain.

Q13. Does Taj Pharma support product registration?
A: Yes, with complete regulatory documentation.

Q14. Can Baclofen ER cause withdrawal symptoms?
A: Yes, sudden discontinuation may cause withdrawal; tapering is recommended.

Q15. What makes Taj Pharma the best exporter?
A: Quality assurance, affordable pricing, and global distribution network.

Q16. What dosage forms are available?
A: Extended-Release Capsules, 40mg.

Q17. Can Baclofen ER cause weight gain?
A: No significant link between Baclofen ER and weight gain.

Q18. Does Taj Pharma supply PCD Pharma Franchise?
A: Yes, Taj Pharma offers franchise opportunities across India.

Q19. What brand names are Baclofen ER known by?
A: Common brands include Kemstro, Lioresal.

Q20. How can buyers contact Taj Pharma?
A: Through Taj Pharma’s official website or via direct export inquiry.