Tibolone

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We manufacture the API in our USFDA inspected, EUGMP Certified, Cofepris Mexcio and Korean MFDS approved facility Swati Spentose Pvt Ltd unit 1. We have filed USDMF and also have EU ASMF for this API. ASMF Filed in: Denmark, Germany, Norway, Sweden, Spain, Cyprus, Czech, Hungary, Ireland, Ita...

We are Swati Spentose Pvt. Ltd. (SSPL), a pharmaceutical company, specializing in manufacturing APIs with backward integration and are also forward integrated into Finished Dosage Forms. Following is our short introduction and product list. Our product list and compliances are given below :

· Unit 1 facility : Facility having approvals/certifications from USFDA, EUGMP, ANVISA (Brazil), WHO GMP, COFEPRIS (Mexico), and Korean MFDS. (AFM Certificate No.: AG12300239).

· Unit 2 facility: A dedicated facility for steroids and hormones. It is PMDA (Japan) inspected and certified by ANVISA (Brazil) and WHO GMP.

· BJPPL: WHO GMP certified and compliant with USFDA and EUGMP.

. Unit 3 facility : This is our finished formulation facility complying with global regulatory standards which will be operational from Q4-2026. 

We are pleased to introduce Swati Spentose Pvt. Ltd., a pharmaceutical company with over four decades of expertise in the development and manufacturing of specialty pharmaceutical products. As part of our strategic expansion, we are pleased to offer Contract Manufacturing (CMO) and Contract Development & Manufacturing (CDMO) services through our newly established, state-of-the-art formulation manufacturing facility.

It has been developed in line with international regulatory standards and incorporates almost  90% automation to ensure consistent product quality, data integrity, and manufacturing efficiency.Our facility has been designed to meet the expectations of global regulated markets & our current manufacturing capabilities include:

Tablets, Hard Gelatin Capsules, Ointments, Creams & Gels, Oral Liquids & Syrups, Sachet Filling & Sealing