Regulatory

The pharma industry both in India and globally is on a constant growth curve and in this dynamic environment the government regulation and policies are always changing.

Madras Pharma is a trend setter when it comes to obtaining DCGI permissions & approvals. We have more than 100 dossiers approvals.

Madras Pharma has a distinguished regulatory department experienced in submitting dossiers in all different formats (as required by the respective country) and getting approvals from both regulated and semi regulated countries. The department in co-ordination Business Development team work towards the needs and wants of the business and their respective country regulations.

Our regulatory team comprises of more than 50 employees with diversified background from various different pharma companies. We have submitted more than 100 dossiers and 100 approvals.

The Bio-Equivalence studies & Clinical Trials are also arranged by the said department as and when required. Likewise, the permission for food products are also obtained from FSSAI after providing all the necessary documents pertaining to the products.

GMP APPROVALS
Facility Dosage Forms Capacity/Annum GMP Approval
Tablets 3.6 billion Digemed Peru, Ivory Coast, Ghana, Ethiopia, Kenya, Uganada, Tanzania, Nigeria, Malawi, Sri Lanka, Myanmar, Nepal, Philippies, Cambodia, Zimbabwe, CIS Except Russia, South America Region(Except Brazil)
Capsules 0.6 billion
Liquids 2000 kilo litres
Creams / Ointments 9 tons
Softgels 1.5 billion caps USFDA-(OTC &Nutra),EU-GMP, Health Canada, INVIMA -Colombia, GCC, Ethiopia, Kenya, IDA Foundation, Maldova, Iran, Uganda, Tanzania, Nigeria, Jordan, Malawi, Zimbabwe, Ivory Coast, Sri Lanka, Ukraine
Injectables- Amp/Vials/Lyophilised 35 million Amp / 24 million vials EU-GMP(Harmone Tablets), Digemed Peru, INVIMA -Colombia, IRAN MOH, PIC's- Malaysia, Ukraine MOH , Kenya, FDB - Ghana , Ivory coast, Zimbabwe , Sri Lanka, Philippines
Hormones-Tables/Softgels 500 million Tabs / 300 million caps
Potent Molecules 600 million Tabs/100 million caps
Tablets/Capsules-General Category 600 million Tabs/250 million caps
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