Penicillamine 125mg Capsules

Penicillamine 125mg Capsules Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Penicillamine 125mg Capsules
B) Penicillamine 250mg Capsules

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Each hard gelatin Capsules contains:
Penicillamine ……………………..……….125mg
Excipients……………………………………..… q.s.
Approved Colours used in empty Capsules Shell.
Read the package leaflet before use.

B) Each hard gelatin Capsules contains:
Penicillamine ……………………..……….250mg
Excipients……………………………………..… q.s.
Approved Colours used in empty Capsules Shell.
Read the package leaflet before use.

THERAPEUTIC INDICATIONS:

to treat Wilson’s disease, severe and active rheumatoid arthritis that has not improved with standard medicines, and cystinuria to prevent painful kidney stones.

CAUTION & WARNING:

CAUTION: regular blood and urine monitoring for severe toxicities, absolute avoidance during pregnancy (except for specific cases like Wilson’s disease) and breastfeeding, and taking the drug on an empty stomach.    

Warning:  Not to be sold by retail without the prescription of a Registered medical practitioner.

STORAGE & DOSAGE:

Storage:   Store at 20° to 25°C (68°TO 77°f) [See USP CONTROLLED Room Temperature]. Dispense in a tightly closed container. protect from excessive heat, light and moisture.

Dosage: As directed by the Physician. Retain in carton until time of use.

Introduction to Penicillamine 125mg Capsules

Penicillamine 125mg Capsules are prescription oral medicines containing penicillamine, a chelating agent and disease-modifying antirheumatic drug (DMARD). The medicine has established therapeutic applications in conditions such as Wilson’s disease, rheumatoid arthritis, and cystinuria, depending on the clinical circumstances and physician’s assessment. Because penicillamine can produce clinically important adverse reactions, its use requires appropriate medical supervision and laboratory monitoring.

Taj Medico is a well-known Penicillamine 125mg Capsules Manufacturer in India, focused on supplying pharmaceutical products to authorized domestic and international buyers. We emphasize product quality, manufacturing consistency, appropriate packaging, and dependable commercial support for pharmaceutical distributors and importers.

The global demand for specialized prescription medicines has increased the importance of reliable pharmaceutical sourcing. Importers and distributors need manufacturers capable of maintaining consistent specifications while supporting documentation, packaging, regulatory, and logistics requirements. As an Indian pharmaceutical manufacturer and exporter, Taj Medico aims to provide a structured supply solution for Penicillamine 125mg Capsules.

Penicillamine 125mg Capsules Manufacturer in India

Taj Medico is an established Manufacturer, Exporter and Supplier of Penicillamine 125mg Capsules from Vapi, Gujarat, India. We focus on quality-oriented pharmaceutical manufacturing and professional supply services for authorized buyers.

Penicillamine works through different mechanisms depending on the condition being treated. In Wilson’s disease, it acts as a chelating agent by binding copper and facilitating its elimination. In rheumatoid arthritis, its disease-modifying activity can influence inflammatory and immune processes. Its use for cystinuria relates to its ability to interact with cystine.

Treatment should always follow the prescribing physician’s instructions. Penicillamine is not a medicine that should be self-administered or adjusted without medical advice.

Penicillamine 125mg Capsules Supplier for Global Buyers

As a Penicillamine 125mg Capsules Supplier, we understand that international pharmaceutical buyers require more than a finished dosage form. They also need dependable communication, appropriate product documentation, packaging options, batch traceability, and coordinated logistics.

We work with authorized pharmaceutical companies, distributors, importers, and institutional procurement organizations to discuss product requirements according to the applicable market regulations.

For export transactions, requirements can vary by destination. Therefore, product registration status, labeling requirements, import permissions, language requirements, certificates, and other regulatory conditions should be confirmed for the intended market before commercialization.

Penicillamine 125mg Capsules Export from India

India has an established pharmaceutical manufacturing and export ecosystem, making Indian suppliers an important sourcing option for international pharmaceutical companies.

Taj Medico supports inquiries concerning Penicillamine 125mg Capsules export from India for authorized buyers. Our export-oriented approach considers product specifications, packaging, documentation, shipment coordination, and destination-market requirements.

Potential markets may include selected countries across Africa, the Middle East, Latin America, South Asia, and other international regions, subject to local registration and import regulations.

Regulatory Documentation for Importers and Distributors

Pharmaceutical importers often require technical and commercial documentation before purchasing or registering a product. Depending on the destination market and transaction requirements, documentation may include product specifications, certificates of analysis, manufacturing information, stability-related documentation, packaging details, and other supporting records.

Where applicable and available for the specific product and market, buyers may request documentation such as:

• Certificate of Analysis (CoA)
• Product specifications
• Batch-related documentation
• Certificate of Pharmaceutical Product (COPP)
• CTD or CTD-related technical documentation
• Manufacturing and quality-system information
• Stability documentation
• Packaging and labeling specifications
• Export documentation
• Other documents required by the destination regulatory authority

The exact documentation package depends on the destination country’s regulations, registration pathway, and buyer requirements.

Custom Packaging and Labeling

Different pharmaceutical markets can have different packaging and labeling requirements. Taj Medico can discuss custom packaging and labeling requirements with eligible buyers, subject to manufacturing capabilities and applicable regulations.

Packaging discussions may include pack size, primary packaging, secondary cartons, artwork requirements, language requirements, batch information, expiry information, storage instructions, and market-specific regulatory statements.

For international orders, artwork and labeling should be reviewed and approved according to the applicable regulatory requirements before production.

Dosage Form, Storage and Shelf-Life Considerations

Penicillamine 125mg is supplied as an oral capsule dosage form. The precise commercial pack configuration and shelf-life should be confirmed from the current approved product specification and batch documentation.

Storage conditions should follow the approved product labeling and manufacturer’s instructions. Pharmaceutical products should generally be protected from unsuitable environmental conditions such as excessive heat, moisture, or direct exposure to inappropriate storage environments.

The prescribed dose and treatment schedule depend on the medical indication, patient characteristics, response to treatment, and physician’s judgment. Buyers and patients should rely on approved prescribing information rather than generic online dosage recommendations.

WHO-GMP Manufacturer India and Export Certifications

Quality systems and regulatory compliance are important factors when selecting a pharmaceutical manufacturing partner. Buyers searching for a WHO-GMP manufacturer in India should evaluate the manufacturer’s applicable certifications, quality systems, manufacturing authorization, inspection history, and product-specific regulatory documentation.

Depending on the destination market and applicable product requirements, international pharmaceutical transactions may involve documents such as WHO-GMP-related documentation, COPP, CTD dossiers, certificates of analysis, and other regulatory records.

EU-GMP certification should not be assumed for every Indian manufacturer or product. Where a specific certification is required, buyers should request current documentary evidence and confirm that it applies to the relevant manufacturing facility and product.

Why Choose Taj Medico as a Penicillamine 125mg Capsules Manufacturer?

State-of-the-Art Manufacturing Approach

We focus on controlled pharmaceutical manufacturing processes designed to support consistency, quality, and traceability. Manufacturing operations involve appropriate quality checks throughout the product lifecycle.

Quality Assurance

Quality assurance is essential for prescription medicines. Our approach emphasizes product specifications, testing, documentation, batch traceability, and controlled pharmaceutical processes.

Competitive Commercial Solutions

International buyers often balance quality, documentation, quantity, packaging, and commercial considerations. We aim to provide competitive pharmaceutical supply solutions while maintaining appropriate quality expectations.

Global Supply Chain Support

Exporting pharmaceutical products requires coordination between manufacturers, distributors, importers, logistics partners, and regulatory stakeholders. We support buyers by maintaining clear communication throughout commercial and supply discussions.

Top 20 Countries and Markets for Pharmaceutical Export Opportunities

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification Table

Safety Information for Penicillamine 125mg Capsules

Penicillamine treatment requires medical supervision. Possible adverse effects can include skin rash, loss of appetite, gastrointestinal discomfort, temporary changes in taste, and changes in blood counts. Protein in urine and reduced platelet counts can also occur.

Some adverse reactions can be serious. Therefore, physicians may order periodic blood and urine tests during treatment. Patients should promptly discuss persistent or concerning symptoms with their healthcare professional.

The medicine should be taken exactly as prescribed. Penicillamine is commonly administered on an empty stomach, often at least one hour before meals or two hours after meals, depending on the prescribing instructions. It may also need to be separated from certain other medicines or iron-containing supplements. Patients should follow their physician’s or pharmacist’s specific instructions.

Frequently Asked Questions About Penicillamine 125mg Capsules

1. What are Penicillamine 125mg Capsules used for?

They may be prescribed for Wilson’s disease, selected cases of severe rheumatoid arthritis, and cystinuria.

2. Who manufactures Penicillamine 125mg Capsules in India?

Taj Medico is a pharmaceutical manufacturer and supplier of Penicillamine 125mg Capsules from Vapi, Gujarat, India.

3. Is Penicillamine a prescription medicine?

Yes. Penicillamine is a prescription medicine and should be used under appropriate medical supervision.

4. How does penicillamine work in Wilson’s disease?

It binds copper and helps facilitate its elimination from the body.

5. Can Penicillamine be used for rheumatoid arthritis?

It may be used in selected cases as a disease-modifying antirheumatic medicine under specialist supervision.

6. What is the role of penicillamine in cystinuria?

It can interact with cystine and may help reduce cystine stone formation in selected patients.

7. How should Penicillamine 125mg Capsules be taken?

They should be taken according to the physician’s prescription and approved product instructions.

8. Should penicillamine be taken with food?

It is commonly taken on an empty stomach, but patients should follow their specific medical instructions.

9. What are common side effects?

Possible effects include gastrointestinal upset, skin rash, appetite changes, taste changes, and blood-count abnormalities.

10. Can penicillamine affect kidney function?

Kidney-related adverse effects can occur, which is why appropriate monitoring may be required.

11. Can penicillamine affect blood counts?

Yes. Changes in blood cells can occur and may require periodic laboratory monitoring.

12. Does penicillamine require regular testing?

Depending on the indication and patient, physicians may monitor blood and urine parameters during treatment.

13. Is Penicillamine 125mg available for export from India?

Authorized buyers can contact Taj Medico to discuss product availability and applicable export requirements.

14. Where is Taj Medico located?

Taj Medico is associated with pharmaceutical operations in Vapi, Gujarat, India.

15. Can international distributors source Penicillamine from Taj Medico?

Authorized pharmaceutical distributors can contact us to discuss sourcing requirements and destination-market regulations.

16. Can customized packaging be requested?

Packaging and labeling requirements can be discussed subject to product specifications, manufacturing capabilities, and regulatory requirements.

17. What documents can pharmaceutical buyers request?

Documentation can include product specifications, CoA, regulatory records, and other documents depending on the destination market and transaction.

18. Does every export market require the same documentation?

No. Documentation requirements vary according to the regulations of each importing country.

19. Is Penicillamine suitable for self-medication?

No. It is a prescription medicine that should be used under qualified medical supervision.

20. How can buyers contact Taj Medico?

Authorized pharmaceutical buyers and distributors can contact Taj Medico to discuss product specifications, quantities, packaging, documentation, and export requirements.

Contact Taj Medico for Penicillamine 125mg Capsules Supply

Pharmaceutical distributors, importers, institutional buyers, and authorized companies seeking a Penicillamine 125mg Capsules Supplier can contact Taj Medico to discuss their requirements.

We can discuss product specifications, commercial quantities, packaging, labeling, regulatory documentation, export markets, and supply requirements according to the buyer’s needs and applicable regulations.