Profile

A competent team of regulatory professionals working for preparation and submission of DMFs as per CTD for our products. One of our custom manufactured product’s DMF is filed in EU countries-filing in process for many more. Registration  process is on for API’s in Brazil, CIS countries.       

 

A new venture of Mehta Pharmaceutical Industries, state-of-the-art facility conforming to USFDA /CGMP/UK-MHRA/EDQM & TGA standards (Under its newly formed Mehta API Pvt. Ltd.) to manufacture APIs just commissioned. Spread across a sprawling 26,580 Sq M, this facility will have dedicated blocks for the manufacturing of APIs.

Erythromycin Derivatives, Azithromycine and its Intermediates, Intermediates of Clarithromycin & Dirithromycin.

Multipurpose facility with Kilo Lab/ Pilot Plant to be commissioned shortly. Separate quality control and quality assurance departments manned by qualified personnel and backed by a well equipped modern laboratory. Seeks strategic alliance from innovator. Generic & dossier companies globally for APIs & Advanced Intermediates.

• Contract Research & Manufacturing of APIs and Intermediates
• Regulatory services

Our strict quality norms at our premises have enabled us to be ahead of our competitors. We have a well-developed quality control unit that is managed by our team of qualified quality controllers. Our complete range of various drug intermediates & medicines is processed under optimum hygiene conditions, so as to sustain their preferred level of purity and effectiveness. The quality controllers at our organization keep a strict vigil throughout every production process and conduct various tests right from procurement of ingredients till the final dispatch to ensure optimum of our products.

 

Our stringent quality checking norms & cGMP, have enabled us in maintaining a competitive position in the market. Further, training and upgrading is a continuous process at our organization.

The Quality Control & Assurance :

• Analytical development supported with modern instruments
• Preparation of drug master file
• Stability studies
• Analytical method validation

Best processes through highly professional R & D work under the guidance of visionary scientists. Offers synthetic processes to get consistent quality product at competitive price. A team of competent Organic Chemists are actively involved in process development of APIs, Advanced Intermediates by cost effective process considering global & regulatory requirements and responding with ICH/FDA/EDQM norms.

Technology transfer and scale -up studies. Preparation of reference & working standards. Impurity profile studies. Offers contract research and custom synthesis services at competitive price.
 
Reactions:

Amidations Heterocycle Synthesis

• Catalytic Hydrogenation Malonic Ester Synthesis
• Chiral Resolution N-Methylation & O-Methylation
• Cyclization Ptc Reaction
• Decarboxylation Quarternization
• Epoxidation High Vacuum Distillation (0.001Mm)
• Esterification

Facility:

Multi purpose production:

Reactor :
SS and GLR – 500 – 5000 liters.

Filtration :
Stainless steel Centrifuges 316: Of 24"- 36" Capacity, SS Neutsche Filters : Of 50- 2000 Lit Capacity

Drying :

• SS Fluid Bed Driers
• Plough Sheer Mixer
• Jet Mill Plough Sheer Mixer

Top store our range of various drug intermediates and medicines, we have a spacious and well-equipped warehouse unit. This unit helps us in storing the complete range in an effectual manner. Further, the sectioned segments in the unit facilitate for easy accommodation and retrieval of the intermediates and derivatives. We have employed a team of skilled warehouse personnel, which takes appropriate measures while storing the medicines and drugs to make these in compliance to safety and hygiene. In addition they ensure that the products are free from impurities and any kind of damage.

 

We have the following facilities at our warehouse unit:

 

• Capable to store bulk consignment
• Controlled temperature
• Fire prevention and extinguishing arrangements
• Well-connected to roads, rails and other transport facilities

 

Apart from storing, we also pack our range in quality packaging material to ensure safe transit at the clients’ end.  Our team of packaging experts provides durable packaging and take care that the products are packed in a hygienic & sterilized conditions.

The prime aim of our organization is to meet the clients’ specific demands and for this we strive to offer them with an effective range of various drug intermediates & medicines. We have with us well-developed processing facilities along with a team of meticulous personnel that facilitate us to provide our clients with stringently formulated medical products to meet daily personal care needs for healthy living. In addition to this, we are also offering our clients based in Brazil and CIS countries with continuum of regulatory services that covers all the documentation process of DMFs and APIs.

 

Moreover, our ultimate objective is to achieve maximum customer satisfaction and thus we have incorporated transparency in business dealings, innovation in production and being ethically firm in our business practices.