Meldonium (Mildronate) Injection Manufacturer & Bulk Supplier for CIS, LATAM, Asia

Meldonium, marketed under the brand name Mildronate, is a cardioprotective metabolic modulator used in the management of ischemic heart disease, chronic heart failure, and cerebrovascular disorders. Originally developed in Latvia, meldonium is widely prescribed across the CIS region, parts of Latin America, and Asia. For hospital procurement teams and pharmaceutical distributors operating in these markets, sourcing meldonium injection in bulk requires a manufacturer that understands the regulatory expectations of CIS pharmacopoeias and tropical-zone stability requirements.

What to look for in a meldonium manufacturer

• WHO-GMP certification with valid Certificate of Pharmaceutical Product (COPP) and Free Sale Certificate (FSC)

• Standard 100 mg/ml strength in 5 ml ampoules, the dosage form used across most CIS and LATAM markets

• CTD or ACTD dossier compilation in your target market’s required format

• Stability data appropriate to your climatic zone, particularly Zone IVa or IVb for tropical export markets

• Contract manufacturing capability if you want to launch meldonium under your own brand

Meldonium injection by Farbe Firma

Farbe Firma Pvt. Ltd. is a WHO-GMP certified manufacturer of meldonium injection (trade name Meldosyl) at 100 mg/ml in 5 ml ampoules. We supply hospital procurement teams, distributors, and government tenders across the CIS region, Latin America, Africa, and Southeast Asia. Our regulatory team supports CTD and ACTD dossier compilation, COPP, FSC, and country-specific registration requirements. We also offer contract manufacturing for partners launching meldonium under their own brand.

Frequently asked questions

Is meldonium the same as Mildronate?

Yes. Meldonium is the international non-proprietary name (INN). Mildronate is the original brand name from Grindeks. The molecule is identical. We supply under the trade name Meldosyl or under your own brand for contract manufacturing customers.

What strengths and packing are available?

Standard offering is meldonium 100 mg/ml in 5 ml glass ampoules (500 mg per ampoule). Custom strengths and packaging are available for bulk tenders and contract manufacturing.

Do you offer dossier support for CIS markets?

Yes. We have active dossier registrations and customer relationships across the CIS region. Our regulatory team prepares dossiers in CTD or ACTD format with country-specific addenda as required.

Request a meldonium quote

If you are sourcing meldonium injection for hospital procurement, distribution contracts, or contract manufacturing, contact Farbe Firma Pvt. Ltd. for a quote within 24 hours.