Description

Notable Tadalafil manufacturers in India include:

Century Pharmaceuticals: Recognized exporter and manufacturer of Tadalafil API and formulations.

Rakshit Drugs Pvt. Ltd.: GMP-certified manufacturer with multiple facilities in Andhra Pradesh and Telangana, exporting to over 80 countries with compliance to USFDA, EDQM, TGA, and other regulatory standards.

Alembic Pharmaceuticals Limited: A well-established company with USFDA-approved ANDA for Tadalafil tablets in multiple strengths (2.5 mg to 20 mg), ensuring therapeutic equivalence to brand-name Cialis.

Srini Pharmaceuticals Pvt. Ltd.: USFDA, TGA, and KFDA approved manufacturing facilities near Hyderabad with extensive experience in API production.

Dapoxetine Manufacturing in India
Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat premature ejaculation. India also produces Dapoxetine API and combination products (e.g., Tadalafil + Dapoxetine tablets) through several pharmaceutical manufacturers, often integrated with Tadalafil for combined treatment of ED and premature ejaculation.

Many Indian manufacturers produce fixed-dose combination tablets containing Tadalafil and Dapoxetine, catering to markets worldwide.

Companies like Anzen Exports and others manufacture both Tadalafil and Dapoxetine APIs and formulations, meeting international quality standards.

Quality and Certifications
Indian manufacturers often comply with international standards such as USFDA, WHO-GMP, EU-GMP, TGA (Australia), KFDA (South Korea), EDQM (Europe), COFEPRIS (Mexico), PMDA (Japan), MFDS (South Korea), and others.

This ensures that APIs and finished products are pure, safe, and reliable for global markets.

Many companies provide full documentation and technical support for product registration in importing countries.