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ofloxacin + betamethasone sodium phosphate

Eye drops 0.3% + 0.1%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA, EU GMP, WHO
Manufacturer #18135
This pharmaceutical company is a global leader specializing in ophthalmic, ENT, and dermatological medications. Founded over four decades ago, they boast a portfolio of over 300 products sold in over 67 countries across regions like the EU, Africa, and Asia. Their key therapeutic areas include dry eyes, eye infections, respiratory tract infections, ear infections, eczema, psoriasis, and acne. They offer various dosage forms such as eye drops, ointments, gels, nasal sprays, creams, and oral medications. The company adheres to international GMP certifications and possesses state-of-the-art manufacturing facilities. Their expertise extends to the development of specialized pharmaceutical excipients, including Stabilized Oxychloro Complex (SOC).

Manufacturer usually replies in 40 days

betamethasone sodium phosphate + betamethasone dipropionate

Injection 2 mg + 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #21424

Established in 1987, this Manufacturer is a fully integrated biopharmaceutical entity specializing in human insulin, analogue insulin, and GLP-1 agents, offering both drug substances and formulations. As a CTD dossier owner and manufacturer, it provides comprehensive services from proof of concept to commercial scale, including yield optimization and contract manufacturing in vials, ampoules, cartridges, and disposable pens. Operating two manufacturing facilities—one in Taloja, Navi Mumbai, certified with WHO-GMP compliance to PIC standards, and another in Pune adhering to European Medicines Evaluation Agency (EMEA) and US FDA standards—the Manufacturer ensures high-quality production. With a workforce of approximately 500 employees, its products are accredited in over 30 countries and regions worldwide. As a GMP manufacturer, it maintains stringent quality standards across all operations. Committed to global health, this CTD dossier owner and manufacturer continues to expand its presence in regulated markets

betamethasone sodium phosphate

Ear/eye drops 0.1 % + 0.5 %

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #21177

This CTD dossier owner and manufacturer, established in the 1980s, operates within South Asia, specializing in the manufacture and supply of pharmaceutical products. Their offerings include tablets, capsules, eye, ear, and nasal drops, as well as oral and injectable suspensions. The company holds EU and US GMP approvals, signifying adherence to high manufacturing standards. Their production lines cater to a diverse range of therapeutic areas, with a focus on infectious diseases, pain management, and ophthalmology. The company boasts a sizable workforce and has a global reach, catering to markets across the world. They are recognized for their commitment to quality, utilizing high-grade chemicals and advanced machinery for production. The company emphasizes its track record in providing quality pharmaceutical products, underscoring its experience in the industry.

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Ofloxacin is a broad-spectrum fluoroquinolone antibiotic belongs to the drug class Fluoroquinolones. This medication is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections and infections of the prostate. Ofloxacin is also used largely topically as eye and ear drops. Ofloxacin should be used only for infections that cannot be treated with safer antibiotics. Manufacturers market Ofloxacin under the Brand name of Floxin, Floxin Otic, Ocuflox. Ofloxacin is advised as a prescription product as well as generic prescription product. Ofloxacin is available in dosage form of Tablets, and Solution / Drops. Tablets are available in dosage strengths of 200 mg, 300 mg, and 400 mg, while solution is available in 3 mg /1 mL dosage strength. Tablets are administered orally and solution / drops are used topically as ear and eyes drops (Auricular / Ophthalmic). The usual dose of Ofloxacin tablets is 200 mg to 400 mg orally for every 12 hours and the dosage varies depending upon the type of infection. For example, the dosage consideration for Bronchitis Exacerbation is 400 mg orally every 12 hours for 10 days, for Complicated Urinary Tract Infections 200 mg orally every 12 hours for 10 days, for Prostatitis 300 mg orally every 12 hours for 6 weeks and for Traveler’s Diarrhea (Off Label) 300 mg orally every 12 hours for 1-3 days. Ofloxacin Tablet and Solution are recommended to be stored at 20° C to 25° C (68° F to 77° F), in well closed containers. Wholesale Price of Ofloxacin The wholesale price for 50 units of 200 mg Ofloxacin oral tablet is approximately $ 7.50 with per unit cost comes at as low as $ 0.15 The per unit cost of 300 mg Ofloxacin oral tablet is approximately $ 0.15 - $ 10.52, which is available for a price range of $ 7.50 - $ 525.97 for 50 tablets whereas for a set of 100 tablets it costs $ 948.20 and the per unit cost comes at $ 9.48 The wholesale price range of Ofloxacin 400 mg oral tablet is approximately $ 429.75 - $ 558.53 for a set of 100 tablets with per unit cost in the range of $ 4.30 - $ 5.59 Ofloxacin Ophthalmic Solution 0.3% is available for a wholesale price range of $ 7.50 - $ 20.94 for 5 milliliters and for 10 milliliters it costs around $ 7.50 - $ 32.39 Ofloxacin - Mechanism of Action Ofloxacin is a bactericidal and broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. Ofloxacin mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. It involves in the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair and recombination. By inhibiting their function, the drug thereby inhibits normal cell division. Finding Ofloxacin Manufacturers and Suppliers To find a trustful partner in any business is one of the tedious tasks and to overcome that challenge and to make one’s work / life easy in finding the trustful and suitable manufacturer and supplier of Ofloxacin one can visit the Pipelinepharma website which helps the buyer in finding the dependable manufacturers and suppliers of Ofloxacin. Pipelinepharma, which is a business-to-business (B2B) licensing marketplace for pharmaceutical products, quickly connects owner with the buyer for the business development. One can filter the product names in unified search engine by its country, category, therapeutic area, forms, dossier and its status, regulatory filings, approvals, and many more.

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