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28 ArticlesUSFDA

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Dr Reddy’s USFDA Inspection of Oncology Formulation Manufacturing Facility at Duvvada – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Dr. Reddy’s oncology formulation manufacturing facility at Duvvada at Visakhapatnam, Andhra Pradesh. ...
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Cadila Healthcare US FDA Inspection of Baddi – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Cadila Healthcare’s formulations manufacturing plant at Baddi. On another note, the company is due ...
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Dr Reddy’s Laboratories US FDA Inspection of Miryalaguda – Form 483 Revealed

Today we cover the Form 483 issued by the US FDA to Dr. Reddy’s API manufacturing plant at Miryalaguda. On another note, the company’s formulation ...
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We Reveal The Observations Made By US FDA’s Inspection Of Natco’s Kothur Facility

True to our promise of keeping a tab on the regulatory inspections of Indian Pharmaceutical companies, we are happy to get our hands on the Form 483 issued ...
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Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Granules OmniChem's Vizag Facility

True to our promise of keeping a tab on the regulatory inspections of Indian Pharmaceutical companies, we are happy to get our hands on the Form 483 issued ...
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We Reveal The Form 483 Issued By US FDAs Inspection Of Divis Laboratories Unit-II At Visakhapatnam

Here is our coverage of the Form 483 issued by the US FDA from the inspection of Divis Laboratories Unit-II located at Visakhapatnam. You can catch all our ...
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Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Sun Pharma’s Halol Facility

True to our promise of keeping a tab on the US FDAs inspection of Sun Pharma’s Halol facility, we are happy to get our hands on the Form 483 issued for ...
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Alkem Laboratories & Divis Laboratories Receive Form 483 From US FDA

With the dust yet to settle on the US FDAs inspection of Sun Pharmaceuticals Mohali, Punjab and Halol, Gujarat plants, 2 more companies have reported receiving ...
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Tracking The Sun Pharma Halol Plant US FDA Inspection

This is not a recommendation to buy or sell the stock. Analyst and family do own some of the positions listed here. Please assume we are biased. With ...
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Alkem Laboratories Recalls 1,739,000 Tablets Of Used For The Treatment Of Oral Diabetes

New Jersey, US based Ascend Laboratories has initiated a recall of Metformin Hydrochloride Tablets manufactured by Mumbai based Alkem Laboratories. The ...