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Drug Master File Document Production Services In India
12 services found
by:Alfred E. Tiefenbacher (GmbH & Co. KG) based inHamburg, GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via product development and registration through to production, timely ...
Manufactured by:Advanced Microdevices Pvt. Ltd. (mdi) based inAmbala Cantt, INDIA
We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug – filter interface and consequently the integrity test values exhibited by the ...
Manufactured by:Advanced Microdevices Pvt. Ltd. (mdi) based inAmbala Cantt, INDIA
Our microbial retention studies qualify the filter under test to repeatedly produce a sterile filtrate with the drug product under simulated worst case process conditions in accordance to: USFDA CDER guidance document on Sterile Drug Products Produced by Aseptic Processing. PDA Technical Report No. 26, Revised 2008 on Sterilizing Filtration of ...
by:Biocon based inElectronic City, INDIA
We are rapidly growing our development, regulatory and clinical expertise, along with world class manufacturing capabilities, to break existing oligopolies and make therapies affordable to patients globally. Biocon Biologics’ state-of-the-art manufacturing facilities are certified by various regulatory agencies from developed and emerging markets. With an unwavering commitment to quality, ...
by:Biocon based inElectronic City, INDIA
Syngene is a publicly listed subsidiary whose core capabilities include highly effective problem-solving and scientific innovation, allied to a clear commitment to safety, quality, and operating excellence. It takes an integrated approach to the disciplines of discovery, development and manufacturing of novel molecules to ensure a quality project delivery on time, every time – all with a ...
Manufactured by:Advanced Microdevices Pvt. Ltd. (mdi) based inAmbala Cantt, INDIA
Filter fluid interaction studies involve physico-chemical compatibility, extractable and adsorption ...
by:Corpbiz Advisors based inNoida, INDIA
Medical Device Registration in India is overseen by the CDSCO, under the Directorate General of Health Services in the Ministry of Health & Family Welfare. To get a Medical Device Registration without any hassle, contact ...
Manufactured by:Piramal Pharma Solutions (PPS) based inMumbai, INDIA
We offer specialized services in clinical trial supply management using a global network of assets, experience, and expertise in streamlining the clinical trial packaging and supply process, thereby ensuring that the study drug is available as ...
Manufactured by:Piramal Pharma Solutions (PPS) based inMumbai, INDIA
We offer pharmaceutical development services for oral solids, liquids, creams, ointment and sterile injectable from our facilities in US, UK and India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct development work in parallel; accelerating time to market and reduce costs for our ...
by:Biocon based inElectronic City, INDIA
Biocon Biologics’ Research and Development organisation is fully integrated to develop high-quality biosimilars (recombinant insulins, monoclonal antibodies and other protein therapeutics) that can be registered in highly regulated markets like USA, Europe and ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
The medical device community is continually faced with the challenge of providing patients with reliable solutions for drug delivery. One of the “go-to” delivery platforms are syringes. Glass or plastic syringes are often used in connection with Luer fittings for injection needles, adapters or transfer devices. Another common syringe platform is pre-filled syringes, filled with a ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
One of the many variables that contribute to drug delivery device reliability is the primary container itself. With our experience with the containers and components from the world’s leading manufacturers, we can assist you with selecting the right components or optimizing your device to an existing container. Leverage our knowledge, experience and partnerships to be well informed for ...