Question 1

What APIs does Valencia Lifesciences manufacture?

Accepted Answer

Valencia Lifesciences manufactures six Active Pharmaceutical Ingredients (APIs): Lidocaine Hydrochloride (CAS 6108-05-0), Lidocaine Base (CAS 137-58-6), Benzocaine (CAS 94-09-7), Meloxicam (CAS 36322-90-4), Prilocaine Hydrochloride (CAS 1786-81-8), and Prilocaine Base (CAS 721-50-6). Combined monthly capacity is 108+ MT.

Question 2

Is Valencia Lifesciences WHO-GMP certified?

Accepted Answer

Yes. Valencia Lifesciences holds WHO-GMP certification for Lidocaine HCl, Lidocaine Base, and Meloxicam, valid through 2026. The facility is also cGMP-compliant and has filed Drug Master Files (DMF) for Lidocaine Hydrochloride and Lidocaine Base, with COPP available for these products.

Question 3

Which countries do you export to?

Accepted Answer

Valencia Lifesciences exports APIs to pharmaceutical companies in 40+ countries worldwide, including the USA, Germany, Brazil, Japan, Australia, South Korea, China, Russia, Turkey, the UAE, and many more. For each product, country-specific availability and regulatory documentation are listed on the product page.

Question 4

What pharmacopoeial standards do your APIs comply with?

Accepted Answer

Our APIs are manufactured to IP, BP, EP, and USP standards. Specific grade availability varies by product - Lidocaine HCl, Lidocaine Base, Benzocaine, and Meloxicam are available in IP/BP/EP/USP grades; Prilocaine HCl and Prilocaine Base are available in BP/EP/USP grades.

Question 5

What is a Drug Master File (DMF) and which products have one?

Accepted Answer

A Drug Master File (DMF) is a confidential document submitted to a regulatory authority (e.g., USFDA, MFDS, NMPA) that contains complete information about an API's manufacturing, processing, and storage. Valencia Lifesciences has filed DMFs for Lidocaine Hydrochloride and Lidocaine Base. South Korea (MFDS) and China (NMPA) submissions are also active.

Question 6

Can I request a sample, COA, or tech pack?

Accepted Answer

Yes. We provide samples, Certificates of Analysis (COA), MSDS, tech packs, and full regulatory documentation on request for evaluation. Contact us at info@valencialifesciences.com or +91-99251-29445 (international sales) to start a request.

Question 7

Where is your manufacturing facility located?

Accepted Answer

Valencia Lifesciences' WHO-GMP compliant manufacturing facility is at Plot No. 1108, Bamanbore GIDC, Rajkot - Ahmedabad NH-47, Sub District & District - Rajkot, Pin 363520, Gujarat, India. The plant features glass-lined and stainless-steel reactors, crystallizers, centrifuges, HPLC and GC analytical systems, clean rooms, HVAC, and an in-house effluent treatment plant.

Question 8

When was Valencia Lifesciences founded?

Accepted Answer

Valencia Lifesciences commenced manufacturing operations in 2020. State GMP certification was obtained in 2021, WHO-GMP in 2024, and Korea MFDS (KDMF) in 2025. Written Confirmation (WC) is currently being applied for Lidocaine HCl, Lidocaine Base, and Meloxicam.