Penicillamine 250mg Capsules

Penicillamine 250mg 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 250mg Capsules

Penicillamine 250mg Capsules are prescription oral medicines containing penicillamine, a chelating agent with established therapeutic applications in Wilson’s disease and cystinuria, as well as selected cases of severe rheumatoid arthritis. Penicillamine binds excess copper in Wilson’s disease and facilitates its elimination through urine. In cystinuria, it interacts with cystine and can help reduce the tendency toward cystine stone formation. For severe rheumatoid arthritis, penicillamine has disease-modifying activity and is used in appropriately selected patients under medical supervision.

Taj Medico is an India-based pharmaceutical manufacturer and supplier operating from the Vapi–Sarigam pharmaceutical manufacturing region of Gujarat. We provide pharmaceutical manufacturing and export support for international buyers seeking dependable sourcing from India. Our manufacturing infrastructure includes capsule production capabilities, quality-control laboratories, regulatory support, packaging services, and export-oriented supply-chain systems.

Global buyers of specialized prescription medicines generally require more than a product quotation. They also look for consistent specifications, appropriate documentation, suitable packaging, dependable production planning, and regulatory support. We structure our pharmaceutical supply services around these requirements while adapting documentation and packaging to the destination market.

Penicillamine 250mg Capsules Manufacturer in India

As a Penicillamine 250mg Capsules Manufacturer in India, Taj Medico focuses on quality-oriented pharmaceutical production and controlled manufacturing practices. WHO explains that GMP is designed to ensure medicinal products are consistently produced and controlled according to appropriate quality standards, with controls extending across production, testing, packaging, labeling, storage, and distribution.

Our manufacturing operations near Vapi, Gujarat, include modern pharmaceutical infrastructure and dedicated quality-control capabilities. Taj Medico states that its facility is WHO-GMP certified and supports production of tablets, capsules, creams, ointments, oral jellies, sachets, and other pharmaceutical dosage forms.

For Penicillamine 250mg Capsules, product-specific availability, specifications, registration status, and documentation should be confirmed with the manufacturer before commercial procurement. This is especially important for regulated pharmaceutical markets where local authorities may require specific technical and administrative documentation.

Penicillamine 250mg Capsules – Therapeutic Overview

Penicillamine is classified as a heavy-metal antagonist and chelating medicine. According to MedlinePlus, it is prescribed for Wilson’s disease and cystinuria and can be used with other treatments for severe rheumatoid arthritis that has not adequately responded to other medicines.

In Wilson’s disease, the medicine binds excess copper and promotes urinary elimination. In cystinuria, penicillamine binds cystine, helping prevent its accumulation and associated stone formation. In rheumatoid arthritis, its mechanism involves modifying certain immune-system actions.

Because penicillamine can produce clinically important adverse effects, it should be supplied through authorized pharmaceutical channels and used only according to applicable prescribing information and professional medical advice.

Administration, Storage and Product Handling

Penicillamine is generally administered orally on an empty stomach. MedlinePlus states that it is usually taken at least one hour before or two hours after a meal, with additional separation requirements applying to certain medicines, iron-containing products, antacids, zinc products, food, and milk. The exact administration schedule depends on the indication and physician’s prescription.

For commercial buyers, storage conditions should follow the approved product labeling and destination-market requirements. A current reference labeling source describes 250mg penicillamine capsules as an oral dosage form.

Shelf life should not be assumed solely from the active ingredient or dosage strength. The approved shelf life of the specific manufactured batch should be confirmed from the manufacturer’s product documentation, packaging, stability data, and Certificate of Analysis where applicable.

Regulatory Documentation for Importers and Pharmaceutical Buyers

International pharmaceutical procurement requires documentation appropriate to the importing country’s regulations. Depending on the market, product registration status, and transaction structure, buyers may request documentation such as:

• Certificate of Analysis (CoA)
• Product specifications
• Batch documentation
• Manufacturing information
• Stability data
• Packaging specifications
• Product registration documents
• Certificate of Pharmaceutical Product (CPP/COPP), where applicable
• Certificate of Origin
• Commercial invoice and packing list
• Shipping documentation
• Technical dossier or CTD documentation, where applicable
• Free Sale Certificate, where applicable
• GMP documentation
• Artwork and labeling files
• Regulatory declarations required by the importing authority

The WHO Certification Scheme provides an internationally recognized framework for pharmaceutical products moving in international commerce, with the Certificate of Pharmaceutical Product serving as its primary document.

Documentation is market-specific. Not every certificate is required for every country, and the availability of a particular document should be confirmed for the product and destination market before publication or commercial commitment.

Custom Packaging and Private Label Support

International buyers frequently require packaging that matches local regulatory requirements, distributor branding, language requirements, pack sizes, and market-specific labeling rules.

Taj Medico provides contract-manufacturing and private-label support, including customized packaging, printed cartons, blister packing, bottle labeling, and export-oriented packaging services.

For Penicillamine 250mg Capsules, packaging specifications can be discussed according to the intended market, regulatory requirements, order quantity, and approved product configuration. Final artwork should always be reviewed against the applicable local regulatory requirements before production.

WHO-GMP Manufacturing Standards and Quality Assurance

A strong pharmaceutical manufacturing partner must integrate quality into the production process rather than relying only on finished-product testing. WHO describes GMP as a quality-assurance system intended to ensure consistent production and control, addressing risks such as contamination, mix-ups, and incorrect labeling.

Taj Medico reports WHO-GMP certification and describes quality-control systems covering raw materials, in-process controls, finished-product testing, stability studies, documentation, and batch release. Its laboratory infrastructure includes analytical instruments and testing capabilities intended to support pharmaceutical quality control.

For buyers searching for a WHO-GMP Manufacturer India, these systems are particularly relevant when sourcing medicines for regulated or quality-sensitive markets.

EU-GMP, PIC/S, COPP and CTD Dossier Support

EU-GMP requirements are governed by the European Union’s pharmaceutical GMP framework. The European Commission maintains EudraLex Volume 4 as the central GMP guidance framework for medicinal products.

Taj Medico’s published information states that its facility is WHO-GMP certified and is designed toward international compliance, with EU-GMP and PIC/S-related capabilities or approvals described on its corporate materials.

For COPP/CPP and CTD dossier requirements, documentation should be evaluated according to the importing authority’s exact requirements. Taj Medico provides regulatory-documentation and dossier-preparation support as part of its global manufacturing and export services.

Global Export Markets for Penicillamine 250mg Capsules

We support pharmaceutical supply requirements for international markets, with export capabilities covering regions including Africa, Asia, Latin America, CIS markets, and the Middle East, subject to product registration and destination-country regulations. Taj Medico publicly describes its export and contract-manufacturing services across these regions.

Top 20 Potential Export Markets

🌍 Nigeria 🌍 Kenya 🌍 South Africa 🌍 UAE 🌍 Saudi Arabia 🌍 Oman 🌍 Vietnam 🌍 Philippines 🌍 Myanmar 🌍 Peru 🌍 Chile 🌍 Bolivia 🌍 Egypt 🌍 Ethiopia 🌍 Tanzania 🌍 Indonesia 🌍 Malaysia 🌍 Colombia 🌍 Ecuador 🌍 Thailand

Why Choose Taj Medico as a Penicillamine 250mg Capsules Supplier?

Modern Pharmaceutical Manufacturing

Taj Medico operates pharmaceutical manufacturing infrastructure in Sarigam GIDC, Gujarat, within the Vapi industrial region. The company reports substantial production capacity across capsules and other dosage forms, supporting both domestic and international requirements.

Quality-Focused Manufacturing

Quality assurance is integrated through raw-material controls, in-process monitoring, analytical testing, stability studies, documentation review, and batch-release procedures.

Competitive Pharmaceutical Supply

Efficient manufacturing infrastructure and scalable production can support competitive commercial solutions for distributors and institutional buyers. Pricing, however, depends on quantity, packaging, destination, regulatory requirements, freight, and commercial terms.

Global Supply Chain Support

We support export-oriented packaging, documentation, logistics coordination, and repeat-order planning. Taj Medico describes international supply capabilities and contract manufacturing services for Africa, Asia, Latin America, CIS countries, and Middle Eastern markets.

Private Label and Contract Manufacturing

Buyers seeking private-label or third-party manufacturing can discuss brand requirements, packaging configurations, quantities, documentation, and destination-market needs with the commercial team.

Technical Product Specification Table

Safety Information for Penicillamine 250mg Capsules

Penicillamine can cause adverse reactions ranging from relatively mild gastrointestinal or taste-related effects to clinically significant blood, kidney, immune, or skin reactions. MedlinePlus lists loss of appetite, taste changes, nausea, vomiting, diarrhea, abdominal pain, and nail or skin changes among possible side effects. Serious symptoms can include unusual bleeding or bruising, fever, rash, breathing problems, and abnormal or bloody urine.

Regular medical follow-up and laboratory testing may be required. The product should not be self-prescribed, and commercial information should never replace approved prescribing information or professional medical advice.

Penicillamine 250mg Capsules Manufacturer PAN India

Taj Medico supports pharmaceutical procurement requirements across India, including buyers searching for a Penicillamine 250mg Capsules Manufacturer in Mumbai, Maharashtra, Gujarat, Delhi, Bengaluru, Hyderabad, Chennai, Kolkata, and other locations.

For PAN India procurement, buyers can request information regarding product availability, pack configuration, minimum order quantity, commercial pricing, documentation, and delivery schedules.

Penicillamine 250mg Capsules PCD Pharma Franchise and Third-Party Manufacturing

Authorized pharmaceutical businesses may also explore third-party manufacturing, private labeling, and franchise-related opportunities where permitted by applicable regulations. Taj Medico offers contract manufacturing services covering product development, manufacturing, packaging, regulatory documentation, and export support.

For a specialized prescription product such as penicillamine, all marketing, distribution, registration, and promotion must comply with the regulations of the relevant jurisdiction.

How to Request a Penicillamine 250mg Capsules Quote

Global buyers and pharmaceutical distributors can provide the following information when submitting an inquiry:

• Required quantity
• Destination country
• Preferred packaging
• Private-label requirements
• Registration status
• Required regulatory documents
• Target delivery timeline
• Shipping preference
• Commercial terms

Providing complete information at the quotation stage helps streamline product evaluation, regulatory review, packaging confirmation, and export planning.

Top 20 FAQs About Penicillamine 250mg Capsules

1. What are Penicillamine 250mg Capsules?

Penicillamine 250mg Capsules are oral prescription medicines containing 250mg of penicillamine. They have chelating and disease-modifying applications.

2. What is Penicillamine 250mg used for?

It is used for Wilson’s disease and cystinuria and may be used in selected cases of severe rheumatoid arthritis under medical supervision.

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

It binds excess copper and helps increase its elimination through urine.

4. Is Penicillamine 250mg a prescription medicine?

Yes. Penicillamine should be used under appropriate medical supervision and according to approved prescribing information.

5. How should Penicillamine 250mg Capsules be taken?

It is generally taken on an empty stomach, at least one hour before or two hours after meals, with specific separation requirements for certain medicines and supplements.

6. Can penicillamine be taken with iron supplements?

Iron can interact with penicillamine. MedlinePlus advises separating iron-containing products from penicillamine according to the specified interval.

7. What are common side effects of penicillamine?

Possible effects include nausea, vomiting, diarrhea, abdominal discomfort, appetite loss, taste changes, and skin or nail changes.

8. Can penicillamine cause protein in urine?

Yes. Proteinuria can occur and may require medical evaluation and laboratory monitoring during treatment.

9. Does penicillamine affect blood counts?

Penicillamine can cause clinically important blood-related adverse reactions, so physicians may order blood tests during treatment.

10. What packaging is available for Penicillamine 250mg Capsules?

Packaging depends on the approved product configuration and destination market. Buyers can discuss blister, bottle, carton, labeling, and private-label requirements with the manufacturer.

11. What is the shelf life of Penicillamine 250mg Capsules?

Shelf life should be confirmed from the current approved product specification, stability data, and batch documentation rather than assumed.

12. How should Penicillamine Capsules be stored?

Storage should follow the approved product label and applicable stability requirements. The referenced U.S. patient information advises room-temperature storage away from excess heat and moisture.

13. Is Taj Medico a Penicillamine 250mg Capsules Manufacturer in India?

Taj Medico operates pharmaceutical manufacturing facilities near Vapi, Gujarat, and offers capsule manufacturing and international pharmaceutical supply services. Product-specific availability should be confirmed directly.

14. Does Taj Medico support pharmaceutical exports?

Yes. Taj Medico describes export and contract-manufacturing capabilities serving international markets across regions including Africa, Asia, Latin America, CIS countries, and the Middle East.

15. Can international buyers request regulatory documentation?

Yes. Documentation can be discussed according to the product and destination country’s requirements, including certificates, specifications, stability information, and dossier-related documents where applicable.

16. Does Taj Medico offer private-label manufacturing?

Taj Medico provides private-label and customized packaging services as part of its contract-manufacturing offering.

17. Can Penicillamine 250mg Capsules be supplied across PAN India?

Pharmaceutical sourcing can be coordinated for authorized buyers across India, subject to product availability, applicable licensing, and commercial requirements.

18. Can Penicillamine 250mg Capsules be exported to Africa and the Middle East?

Potentially, subject to registration, import authorization, labeling, documentation, and other requirements in each destination country.

19. What should an importer provide when requesting a quotation?

Importers should provide the destination country, quantity, packaging preference, regulatory requirements, registration status, delivery timeline, and documentation requirements.

20. How can global buyers contact Taj Medico for Penicillamine 250mg Capsules?

Buyers can contact Taj Medico through its official website and provide their quantity, destination market, packaging requirements, and regulatory-documentation needs for a commercial evaluation.